FDA Orange Book - Triamcinolone Acetonide
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`OTC
`TRIAMCINOLONE ACETONIDE
`OTC
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
`DISCN
`NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
`DISCN
`NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`
`AT
`
`AP
`
`AP
`
`AT
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Approval Date
`TE Code RLD RS Applicant Holder
`Appl No
`Product Number
`Dosage Form
`Route
`Strength
`Proprietary Name
`Jul 11, 1991
`SANOFI AVENTIS US LLC
`N019798 001
`AEROSOL, METERED NASAL
`0.055MG/INH
`NASACORT
`LUPIN ATLANTIS HOLDING SA SWITZERLANDFeb 4, 2000
`N020120 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`ALLERNAZE
`SANOFI AVENTIS US LLC
`Apr 7, 2004
`N020784 001
`SPRAY, METERED
`NASAL
`0.055MG/SPRAY
`NASACORT HFA
`PERRIGO ISRAEL PHARMACEUTICALS LTD Jul 30, 2009
`A078104
`001
`SPRAY, METERED
`NASAL
`0.055MG/SPRAY
`TRIAMCINOLONE ACETONIDE
`RLD RS SANOFI AVENTIS US LLC
`Oct 11, 2013
`N020468 002
`SPRAY, METERED
`NASAL
`0.055MG/SPRAY
`NASACORT ALLERGY 24 HOUR
`PERRIGO ISRAEL PHARMACEUTICALS LTD Nov 14, 2014
`A078104
`002
`SPRAY, METERED
`NASAL
`0.055MG/SPRAY
`TRIAMCINOLONE ACETONIDE
`RS TARO PHARMACEUTICALS USA INC
`Oct 1, 1986
`A070730
`001
`PASTE
`DENTAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`TARO PHARMACEUTICALS USA INC
`Jul 6, 1987
`A071383
`001
`PASTE
`DENTAL
`0.1%
`ORALONE
`LYNE LABORATORIES INC
`Jul 1, 2010
`AT
`A040771
`001
`PASTE
`DENTAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`AKORN INC
`Aug 11, 2016
`AT
`A206312
`001
`PASTE
`DENTAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`G AND W LABORATORIES INC
`Jan 12, 2017
`AT
`A205592
`001
`PASTE
`DENTAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`DELCOR ASSET CORP
`Approved Prior to Jan 1, 1982
`N012097 001
`PASTE
`DENTAL
`0.1% **Federal Register determination tRLD
`KENALOG IN ORABASE
`ABBVIE INC
`Apr 23, 1982
`N018117 001
`AEROSOL, METERED INHALATION
`0.1MG/INH
`AZMACORT
`PARNELL PHARMACEUTICALS INC
`Oct 16, 1987
`N019503 001
`INJECTABLE
`INJECTION
`3MG/ML
`TRIAMCINOLONE ACETONIDE
`SANDOZ INC
`May 27, 2009
`A090166
`001
`INJECTABLE
`INJECTION
`10MG/ML
`TRIAMCINOLONE ACETONIDE
`SANDOZ INC
`Jun 1, 2009
`A090164
`001
`INJECTABLE
`INJECTION
`40MG/ML
`TRIAMCINOLONE ACETONIDE
`AMNEAL PHARMACEUTICALS CO GMBH
`Dec 11, 2017
`A207550
`001
`INJECTABLE
`INJECTION
`40MG/ML
`TRIAMCINOLONE ACETONIDE
`APOTHECON INC DIV BRISTOL MYERS SQUIBApproved Prior to Jan 1, 1982
`RLD
`N012041 001
`INJECTABLE
`INJECTION
`10MG/ML
`KENALOG-10
`RLD RS APOTHECON INC DIV BRISTOL MYERS SQUIBApproved Prior to Jan 1, 1982
`N014901 001
`INJECTABLE
`INJECTION
`40MG/ML
`KENALOG-40
`WATSON LABORATORIES INC
`Approved Prior to Jan 1, 1982
`A085825
`001
`INJECTABLE
`INJECTION
`40MG/ML
`TRIAMCINOLONE ACETONIDE
`RLD RS FLEXION THERAPEUTICS INC
`Oct 6, 2017
`N208845 001
`FOR SUSPENSION, EXTEINTRA-ARTICULAR
`32MG/VIAL
`ZILRETTA
`N022220 001
`INJECTABLE
`INTRA-ARTICULAR, INT 8MG/0.1ML (8MG/0.1ML) **Federal RegRLD
`ALLERGAN INC
`Jun 16, 2008
`TRIVARIS
`N022048 001
`INJECTABLE
`INTRAVITREAL
`40MG/ML (40MG/ML)
`RLD RS NOVARTIS PHARMACEUTICALS CORP
`Nov 29, 2007
`TRIESENCE
`A087798
`001
`CREAM
`TOPICAL
`0.1%
`ACTAVIS MID ATLANTIC LLC
`Jun 4, 1982
`TRIAMCINOLONE ACETONIDE
`A087797
`001
`CREAM
`TOPICAL
`0%
`ALPHARMA US PHARMACEUTICALS DIVISIO Jun 7, 1982
`TRIAMCINOLONE ACETONIDE
`A087921
`001
`CREAM
`TOPICAL
`0%
`PHARMAFAIR INC
`Aug 10, 1982
`TRIAMCINOLONE ACETONIDE
`A087912
`001
`CREAM
`TOPICAL
`0.1%
`PHARMAFAIR INC
`Aug 10, 1982
`TRIAMCINOLONE ACETONIDE
`A087922
`001
`CREAM
`TOPICAL
`0.5%
`PHARMAFAIR INC
`Aug 10, 1982
`TRIAMCINOLONE ACETONIDE
`A088196
`001
`CREAM
`TOPICAL
`0%
`SAVAGE LABORATORIES INC DIV ALTANA INMar 25, 1983
`TRYMEX
`A088197
`001
`CREAM
`TOPICAL
`0.1%
`SAVAGE LABORATORIES INC DIV ALTANA INMar 25, 1983
`TRYMEX
`A088198
`001
`CREAM
`TOPICAL
`0.5%
`SAVAGE LABORATORIES INC DIV ALTANA INMar 25, 1983
`TRYMEX
`A087932
`001
`CREAM
`TOPICAL
`0%
`AMBIX LABORATORIES DIV ORGANICS CORPMay 9, 1983
`TRIAMCINOLONE ACETONIDE
`A087990
`001
`CREAM
`TOPICAL
`0%
`PHARMADERM DIV ALTANA INC
`Jul 7, 1983
`TRIAMCINOLONE ACETONIDE
`A087991
`001
`CREAM
`TOPICAL
`0.1%
`PHARMADERM DIV ALTANA INC
`Jul 7, 1983
`TRIAMCINOLONE ACETONIDE
`A087992
`001
`CREAM
`TOPICAL
`0.5%
`PHARMADERM DIV ALTANA INC
`Jul 7, 1983
`TRIAMCINOLONE ACETONIDE
`A088094
`001
`CREAM
`TOPICAL
`0%
`MORTON GROVE PHARMACEUTICALS INC Sep 1, 1983
`TRIAMCINOLONE ACETONIDE
`A088095
`001
`CREAM
`TOPICAL
`0.1%
`MORTON GROVE PHARMACEUTICALS INC Sep 1, 1983
`TRIAMCINOLONE ACETONIDE
`A088096
`001
`CREAM
`TOPICAL
`0.5%
`MORTON GROVE PHARMACEUTICALS INC Sep 1, 1983
`TRIAMCINOLONE ACETONIDE
`A088042
`001
`CREAM
`TOPICAL
`0.1%
`CROWN LABORATORIES INC
`Mar 19, 1984
`TRIDERM
`A088818
`001
`CREAM
`TOPICAL
`0%
`ASTELLAS PHARMA US INC
`Oct 16, 1984
`ARISTOCORT A
`A088819
`001
`CREAM
`TOPICAL
`0.1%
`ASTELLAS PHARMA US INC
`Oct 16, 1984
`ARISTOCORT A
`A088820
`001
`CREAM
`TOPICAL
`0.5%
`ASTELLAS PHARMA US INC
`Oct 16, 1984
`ARISTOCORT A
`A060576
`002
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1% **Federal Register deteDELCOR ASSET CORP
`May 1, 1985
`MYCOLOG-II
`A062606
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1% **Federal Register deteMYLAN PHARMACEUTICALS INC
`May 15, 1985
`MYCOLOG-II
`A062367
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`AT
`G AND W LABORATORIES INC
`May 28, 1985
`MYKACET
`NYSTATIN AND TRIAMCINOLONE ACETA062186
`002
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`PERRIGO NEW YORK INC
`Jun 6, 1985
`MYCO-TRIACET II
`A061954
`002
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TEVA PHARMACEUTICALS USA INC
`Sep 20, 1985
`NYSTATIN AND TRIAMCINOLONE ACETA062599
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`FOUGERA PHARMACEUTICALS INC
`Oct 8, 1985
`MYTREX F
`A062597
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`SAVAGE LABORATORIES INC DIV ALTANA INOct 8, 1985
`NYSTATIN TRIAMCINOLONE ACETONIDA062596
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`PHARMADERM DIV ALTANA INC
`Oct 8, 1985
`MYTREX A
`A062598
`001
`CREAM
`TOPICAL
`EQ 3.5MG BASE/GM; 0.1%
`SAVAGE LABORATORIES INC DIV ALTANA INJul 21, 1986
`NEOMYCIN SULFATE-TRIAMCINOLONE A062600
`001
`CREAM
`TOPICAL
`EQ 3.5MG BASE/GM; 0.1%
`E FOUGERA DIV ALTANA INC
`Jul 21, 1986
`NEOMYCIN SULFATE-TRIAMCINOLONE A062595
`001
`CREAM
`TOPICAL
`EQ 3.5MG BASE/GM; 0.1%
`PHARMADERM DIV ALTANA INC
`Jul 21, 1986
`NYSTATIN AND TRIAMCINOLONE ACETA062657
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`PHARMAFAIR INC
`Jul 30, 1986
`NYSTATIN AND TRIAMCINOLONE ACETA062347
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TARO PHARMACEUTICALS USA INC
`Mar 30, 1987
`NYSTATIN AND TRIAMCINOLONE ACETA062364
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`RS TARO PHARMACEUTICALS USA INC
`Dec 22, 1987
`TRIATEX
`A087430
`001
`CREAM
`TOPICAL
`0%
`IVAX PHARMACEUTICALS INC
`Nov 1, 1988
`TRIATEX
`A087429
`001
`CREAM
`TOPICAL
`0.1%
`IVAX PHARMACEUTICALS INC
`Nov 1, 1988
`TRIATEX
`A087428
`001
`CREAM
`TOPICAL
`0.5%
`IVAX PHARMACEUTICALS INC
`Nov 1, 1988
`NYSTATIN AND TRIAMCINOLONE ACETA063010
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`ALPHARMA US PHARMACEUTICALS DIVISIO Dec 20, 1988
`TRIAMCINOLONE ACETONIDE
`A089274
`001
`CREAM
`TOPICAL
`0%
`TOPIDERM INC
`Feb 21, 1989
`TRIAMCINOLONE ACETONIDE
`A089275
`001
`CREAM
`TOPICAL
`0.1%
`TOPIDERM INC
`Feb 21, 1989
`TRIAMCINOLONE ACETONIDE
`A089276
`001
`CREAM
`TOPICAL
`0.5%
`TOPIDERM INC
`Feb 21, 1989
`TRIAMCINOLONE ACETONIDE
`A089797
`001
`CREAM
`TOPICAL
`0%
`G AND W LABORATORIES INC
`May 31, 1991
`TRIAMCINOLONE ACETONIDE
`A089798
`001
`CREAM
`TOPICAL
`0.1%
`G AND W LABORATORIES INC
`May 31, 1991
`TRIAMCINOLONE ACETONIDE
`A040038
`001
`CREAM
`TOPICAL
`0%
`TARO PHARMACEUTICALS USA INC
`Oct 26, 1994
`TRIAMCINOLONE ACETONIDE
`A040039
`001
`CREAM
`TOPICAL
`0.1%
`TARO PHARMACEUTICALS USA INC
`Nov 26, 1997
`TRIAMCINOLONE ACETONIDE
`A040671
`001
`CREAM
`TOPICAL
`0%
`VINTAGE PHARMACEUTICALS LLC
`Jun 9, 2006
`TRIAMCINOLONE ACETONIDE
`A040671
`002
`CREAM
`TOPICAL
`0.1%
`VINTAGE PHARMACEUTICALS LLC
`Jun 9, 2006
`
`AT
`
`AT
`
`AT
`AT
`
`AT
`AT
`AT
`
`Exhibit 1111
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 3
`
`000001
`
`

`

`FDA Orange Book - Triamcinolone Acetonide
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Approval Date
`TE Code RLD RS Applicant Holder
`Appl No
`Product Number
`Dosage Form
`Route
`Strength
`Proprietary Name
`Mar 25, 2015
`AT
`CROWN LABORATORIES INC
`A088042
`002
`CREAM
`TOPICAL
`0%
`TRIDERM
`Mar 25, 2015
`AT
`CROWN LABORATORIES INC
`A088042
`003
`CREAM
`TOPICAL
`0.5%
`TRIDERM
`Aug 5, 2016
`AT
`GLENMARK PHARMACEUTICALS LTD
`A207117
`001
`CREAM
`TOPICAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`Oct 24, 2016
`AT
`GLENMARK PHARMACEUTICALS LTD
`NYSTATIN AND TRIAMCINOLONE ACETA208136
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`Oct 26, 2016
`AT
`DR REDDYS LABORATORIES LTD
`NYSTATIN AND TRIAMCINOLONE ACETA208326
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`Feb 1, 2017
`AT
`LUPIN ATLANTIS HOLDINGS SA
`TRIAMCINOLONE ACETONIDE
`A208763
`001
`CREAM
`TOPICAL
`0%
`Feb 1, 2017
`AT
`LUPIN ATLANTIS HOLDINGS SA
`TRIAMCINOLONE ACETONIDE
`A208763
`002
`CREAM
`TOPICAL
`0.1%
`Feb 1, 2017
`AT
`LUPIN ATLANTIS HOLDINGS SA
`TRIAMCINOLONE ACETONIDE
`A208763
`003
`CREAM
`TOPICAL
`0.5%
`Aug 14, 2017
`AT
`PERRIGO UK FINCO LTD PARTNERSHIP
`NYSTATIN AND TRIAMCINOLONE ACETA208479
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`Sep 18, 2017
`AT
`TELIGENT PHARMA INC
`TRIAMCINOLONE ACETONIDE
`A208848
`001
`CREAM
`TOPICAL
`0.1%
`Dec 26, 2017
`AT
`CROWN LABORATORIES INC
`NYSTATIN AND TRIAMCINOLONE ACETA207730
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`Dec 26, 2017
`AT
`ALKEM LABORATORIES LTD
`TRIAMCINOLONE ACETONIDE
`A207651
`001
`CREAM
`TOPICAL
`0%
`Dec 26, 2017
`AT
`ALKEM LABORATORIES LTD
`TRIAMCINOLONE ACETONIDE
`A207651
`002
`CREAM
`TOPICAL
`0.1%
`Dec 26, 2017
`AT
`ALKEM LABORATORIES LTD
`TRIAMCINOLONE ACETONIDE
`A207651
`003
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`AT
`RS FOUGERA PHARMACEUTICALS INC
`TRIAMCINOLONE ACETONIDE
`A085692
`001
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`AT
`MYLAN PHARMACEUTICALS INC
`TRIAMCINOLONE ACETONIDE
`N011601 003
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`AT
`PERRIGO NEW YORK INC
`TRIAMCINOLONE ACETONIDE
`A086415
`001
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`AT
`RS FOUGERA PHARMACEUTICALS INC
`TRIAMCINOLONE ACETONIDE
`A085692
`003
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`AT
`MYLAN PHARMACEUTICALS INC
`TRIAMCINOLONE ACETONIDE
`N011601 006
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`AT
`PERRIGO NEW YORK INC
`TRIAMCINOLONE ACETONIDE
`A086414
`001
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`AT
`RS FOUGERA PHARMACEUTICALS INC
`TRIAMCINOLONE ACETONIDE
`A085692
`002
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`AT
`PERRIGO NEW YORK INC
`TRIAMCINOLONE ACETONIDE
`A086413
`001
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOCORT
`A083017
`003
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOCORT
`A083016
`004
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOCORT
`A083015
`002
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOCORT A
`A083017
`004
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOCORT A
`A083016
`005
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOCORT A
`A083015
`003
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`IVAX PHARMACEUTICALS INC
`FLUTEX
`A085539
`001
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`IVAX PHARMACEUTICALS INC
`FLUTEX
`A085539
`002
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`IVAX PHARMACEUTICALS INC
`FLUTEX
`A085539
`003
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`DELCOR ASSET CORP
`KENALOG
`A083943
`001
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`DELCOR ASSET CORP
`KENALOG-H
`A086240
`001
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`TEVA PHARMACEUTICALS USA INC
`TRIACET
`A084908
`001
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`TEVA PHARMACEUTICALS USA INC
`TRIACET
`A084908
`002
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`TEVA PHARMACEUTICALS USA INC
`TRIACET
`A084908
`003
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`SOLVAY PHARMACEUTICALS
`TRIACORT
`A087113
`001
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`TARO PHARMACEUTICALS USA INC
`TRIAMCINOLONE ACETONIDE
`A086277
`001
`CREAM
`TOPICAL
`0%
`Approved Prior to Jan 1, 1982
`TARO PHARMACEUTICALS USA INC
`TRIAMCINOLONE ACETONIDE
`A086276
`001
`CREAM
`TOPICAL
`0.1%
`Approved Prior to Jan 1, 1982
`TARO PHARMACEUTICALS USA INC
`TRIAMCINOLONE ACETONIDE
`A086275
`001
`CREAM
`TOPICAL
`0.5%
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`ARISTOGEL
`A083380
`001
`GEL
`TOPICAL
`0.1%
`ALPHARMA US PHARMACEUTICALS DIVISIO Sep 8, 1982
`TRIAMCINOLONE ACETONIDE
`A087191
`001
`LOTION
`TOPICAL
`0%
`ALPHARMA US PHARMACEUTICALS DIVISIO Sep 8, 1982
`TRIAMCINOLONE ACETONIDE
`A087192
`001
`LOTION
`TOPICAL
`0.1%
`RS WOCKHARDT EU OPERATIONS SWISS AG
`Apr 1, 1985
`AT
`TRIAMCINOLONE ACETONIDE
`A088450
`001
`LOTION
`TOPICAL
`0%
`RS WOCKHARDT EU OPERATIONS (SWISS) AG Apr 3, 1985
`AT
`TRIAMCINOLONE ACETONIDE
`A088451
`001
`LOTION
`TOPICAL
`0.1%
`G AND W LABORATORIES INC
`Aug 14, 1986
`AT
`TRIAMCINOLONE ACETONIDE
`A089129
`001
`LOTION
`TOPICAL
`0.1%
`FOUGERA PHARMACEUTICALS INC
`Apr 21, 2003
`AT
`TRIAMCINOLONE ACETONIDE
`A040467
`001
`LOTION
`TOPICAL
`0%
`FOUGERA PHARMACEUTICALS INC
`Apr 21, 2003
`AT
`TRIAMCINOLONE ACETONIDE
`A040467
`002
`LOTION
`TOPICAL
`0.1%
`VINTAGE PHARMACEUTICALS LLC
`Dec 13, 2006
`AT
`TRIAMCINOLONE ACETONIDE
`A040672
`002
`LOTION
`TOPICAL
`0.1%
`AKORN INC
`May 8, 2013
`AT
`TRIAMCINOLONE ACETONIDE
`A202374
`001
`LOTION
`TOPICAL
`0%
`AKORN INC
`May 8, 2013
`AT
`TRIAMCINOLONE ACETONIDE
`A202374
`002
`LOTION
`TOPICAL
`0.1%
`TELIGENT PHARMA INC
`Jul 7, 2016
`AT
`TRIAMCINOLONE ACETONIDE
`A204608
`001
`LOTION
`TOPICAL
`0%
`TELIGENT PHARMA INC
`Jul 7, 2016
`AT
`TRIAMCINOLONE ACETONIDE
`A204606
`001
`LOTION
`TOPICAL
`0.1%
`
`
`
` DELCOR ASSET CORP
`
`
`
`
` Approved Prior to Jan 1, 1982
`
`0.025% **Federal Register determinatio RLD
`
`KENALOG
`N011602 003
`LOTION
`TOPICAL
`
`
`
`
` 0.025% **Federal Register determination that proDELCOR ASSET CORP
`
`
`
` Approved Prior to Jan 1, 1982
`
`
`KENALOG
`A084343
`001
`LOTION
`TOPICAL
`
`
`
`KENALOG
`N011602 001
`LOTION
`TOPICAL
`0.1% **Federal Register determination t
`
` RLD
` DELCOR ASSET CORP
` Approved Prior to Jan 1, 1982
`
`
`
`
`
`
`
`
`KENALOG
`A084343
`002
`LOTION
`TOPICAL
`0.1% **Federal Register determination that prod
`
` DELCOR ASSET CORP
`
`
`
` Approved Prior to Jan 1, 1982
`
`
`TRIAMCINOLONE ACETONIDE
`A087799
`001
`OINTMENT
`TOPICAL
`0.1%
`ACTAVIS MID ATLANTIC LLC
`Jun 7, 1982
`TRIAMCINOLONE ACETONIDE
`A087902
`001
`OINTMENT
`TOPICAL
`0.1%
`TARO PHARMACEUTICALS USA INC
`Dec 27, 1982
`TRIAMCINOLONE ACETONIDE
`A088090
`001
`OINTMENT
`TOPICAL
`0%
`MORTON GROVE PHARMACEUTICALS INC Sep 1, 1983
`TRIAMCINOLONE ACETONIDE
`A088091
`001
`OINTMENT
`TOPICAL
`0.1%
`MORTON GROVE PHARMACEUTICALS INC Sep 1, 1983
`TRIAMCINOLONE ACETONIDE
`A088092
`001
`OINTMENT
`TOPICAL
`0.5%
`MORTON GROVE PHARMACEUTICALS INC Sep 1, 1983
`TRIAMCINOLONE ACETONIDE
`A088692
`001
`OINTMENT
`TOPICAL
`0%
`PHARMADERM DIV ALTANA INC
`Aug 2, 1984
`TRIAMCINOLONE ACETONIDE
`A088690
`001
`OINTMENT
`TOPICAL
`0.1%
`PHARMADERM DIV ALTANA INC
`Aug 2, 1984
`TRYMEX
`A088693
`001
`OINTMENT
`TOPICAL
`0%
`SAVAGE LABORATORIES INC DIV ALTANA INAug 2, 1984
`TRYMEX
`A088691
`001
`OINTMENT
`TOPICAL
`0.1%
`SAVAGE LABORATORIES INC DIV ALTANA INAug 2, 1984
`ARISTOCORT A
`A088780
`001
`OINTMENT
`TOPICAL
`0.1%
`ASTELLAS PHARMA US INC
`Oct 1, 1984
`ARISTOCORT A
`A088781
`001
`OINTMENT
`TOPICAL
`0.5%
`ASTELLAS PHARMA US INC
`Oct 5, 1984
`MYCOLOG-II
`A060572
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1% **Federal Register dete
` MYLAN PHARMACEUTICALS INC
`
`
`
`
`
` Jun 28, 1985
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 2 of 3
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`RLD
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`RLD
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`000002
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`

`

`FDA Orange Book - Triamcinolone Acetonide
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
`DISCN
`NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
`DISCN
`NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
`DISCN
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`NYSTATIN; TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`DISCN
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`RX
`TRIAMCINOLONE ACETONIDE
`
`AT
`
`AT
`AT
`
`AT
`AT
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Proprietary Name
`Product Number
`Dosage Form
`Route
`Strength
`NYSTATIN AND TRIAMCINOLONE ACETA062602
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`MYTREX F
`A062601
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN-TRIAMCINOLONE ACETONIDA062603
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA062280
`002
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`MYCO-TRIACET II
`A062045
`002
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`MYTREX A
`A062609
`001
`OINTMENT
`TOPICAL
`EQ 3.5MG BASE/GM; 0.1%
`NEOMYCIN SULFATE-TRIAMCINOLONE A062608
`001
`OINTMENT
`TOPICAL
`EQ 3.5MG BASE/GM; 0.1%
`NEOMYCIN SULFATE-TRIAMCINOLONE A062607
`001
`OINTMENT
`TOPICAL
`EQ 3.5MG BASE/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA062656
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`MYKACET
`A062733
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`FLUTEX
`A087375
`001
`OINTMENT
`TOPICAL
`0%
`FLUTEX
`A087377
`001
`OINTMENT
`TOPICAL
`0.1%
`FLUTEX
`A087376
`001
`OINTMENT
`TOPICAL
`0.5%
`TRIAMCINOLONE ACETONIDE
`A089795
`001
`OINTMENT
`TOPICAL
`0%
`TRIAMCINOLONE ACETONIDE
`A089796
`001
`OINTMENT
`TOPICAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`A089913
`001
`OINTMENT
`TOPICAL
`0.5%
`NYSTATIN AND TRIAMCINOLONE ACETA063305
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TRIAMCINOLONE ACETONIDE
`A040037
`001
`OINTMENT
`TOPICAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`A040040
`001
`OINTMENT
`TOPICAL
`0%
`TRIAMCINOLONE ACETONIDE IN ABSO A089595
`001
`OINTMENT
`TOPICAL
`0%
`TRIAMCINOLONE ACETONIDE
`A040374
`001
`OINTMENT
`TOPICAL
`0%
`TRIAMCINOLONE ACETONIDE
`A040386
`001
`OINTMENT
`TOPICAL
`0.5%
`TRIAMCINOLONE ACETONIDE
`A205373
`001
`OINTMENT
`TOPICAL
`0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA208300
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TRIAMCINOLONE ACETONIDE
`A206379
`001
`OINTMENT
`TOPICAL
`0.5%
`NYSTATIN AND TRIAMCINOLONE ACETA207380
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA206785
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA208287
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA207741
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA209990
`001
`CREAM
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TRIAMCINOLONE ACETONIDE
`A208590
`001
`OINTMENT
`TOPICAL
`0.5%
`NYSTATIN AND TRIAMCINOLONE ACETA207217
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TRIAMCINOLONE ACETONIDE
`A208320
`001
`OINTMENT
`TOPICAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`A208925
`001
`OINTMENT
`TOPICAL
`0.5%
`NYSTATIN AND TRIAMCINOLONE ACETA207731
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`NYSTATIN AND TRIAMCINOLONE ACETA210077
`001
`OINTMENT
`TOPICAL
`100,000 UNITS/GM; 0.1%
`TRIAMCINOLONE ACETONIDE
`A085691
`001
`OINTMENT
`TOPICAL
`0%
`TRIAMCINOLONE ACETONIDE
`A087356
`001
`OINTMENT
`TOPICAL
`0%
`TRIAMCINOLONE ACETONIDE
`A085691
`003
`OINTMENT
`TOPICAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`A087357
`001
`OINTMENT
`TOPICAL
`0.1%
`TRIAMCINOLONE ACETONIDE
`A085691
`002
`OINTMENT
`TOPICAL
`0.5%
`TRIAMCINOLONE ACETONIDE
`A087385
`001
`OINTMENT
`TOPICAL
`0.5%
`ARISTOCORT
`A080750
`004
`OINTMENT
`TOPICAL
`0.1%
`ARISTOCORT
`A080745
`002
`OINTMENT
`TOPICAL
`0.5% **Federal Register determination that prod
`ARISTOCORT A
`A080750
`003
`OINTMENT
`TOPICAL
`0.1%
`ARISTOCORT A
`A080745
`003
`OINTMENT
`TOPICAL
`0.5% **Federal Register determination that prod
`KENALOG
`N011600 003
`OINTMENT
`TOPICAL
`0%
`RLD
`KENALOG
`N011600 001
`OINTMENT
`TOPICAL
`0.1%
`RLD
`KENALOG
`A083944
`001
`OINTMENT
`TOPICAL
`0.5% **Federal Register determination that prod
`TRIAMCINOLONE ACETONIDE
`A205782
`001
`SPRAY
`TOPICAL
`0.147MG/GM
`AT
`TRIAMCINOLONE ACETONIDE
`A207094
`001
`SPRAY
`TOPICAL
`0.147MG/GM
`AT
`TRIAMCINOLONE ACETONIDE
`A206786
`001
`SPRAY
`TOPICAL
`0.147MG/GM
`AT
`KENALOG
`N012104 001
`SPRAY
`TOPICAL
`0.147MG/GM
`AT
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Oct 9, 1985
`AT
`FOUGERA PHARMACEUTICALS INC
`SAVAGE LABORATORIES INC DIV ALTANA INOct 9, 1985
`PHARMADERM DIV ALTANA INC
`Oct 9, 1985
`PERRIGO NEW YORK INC
`Oct 10, 1985
`TEVA PHARMACEUTICALS USA INC
`Nov 26, 1985
`SAVAGE LABORATORIES INC DIV ALTANA INMay 23, 1986
`E FOUGERA DIV ALTANA INC
`May 23, 1986
`PHARMADERM DIV ALTANA INC
`May 23, 1986
`PHARMAFAIR INC
`Jul 30, 1986
`G AND W LABORATORIES INC
`Mar 6, 1987
`IVAX PHARMACEUTICALS INC
`Nov 1, 1988
`IVAX PHARMACEUTICALS INC
`Nov 1, 1988
`IVAX PHARMACEUTICALS INC
`Nov 1, 1988
`G AND W LABORATORIES INC
`Dec 23, 1988
`G AND W LABORATORIES INC
`Dec 23, 1988
`ALPHARMA US PHARMACEUTICALS DIVISIO Dec 23, 1988
`RS TARO PHARMACEUTICALS USA INC
`Mar 29, 1993
`TARO PHARMACEUTICALS USA INC
`Sep 30, 1994
`TARO PHARMACEUTICALS USA INC
`Sep 30, 1994
`RS CMP PHARMA INC
`Mar 23, 1995
`TARO PHARMACEUTICALS USA INC
`Jun 5, 2001
`TARO PHARMACEUTICALS USA INC
`Jun 5, 2001
`TELIGENT PHARMA INC
`May 13, 2016
`GLENMARK PHARMACEUTICALS LTD
`Jun 23, 2016
`GLENMARK PHARMACEUTICALS LTD
`Jul 22, 2016
`PERRIGO UK FINCO LTD PARTNERSHIP
`Dec 20, 2016
`RICONPHARMA LLC
`Dec 29, 2016
`TELIGENT PHARMA INC
`Dec 30, 2016
`DR REDDYS LABORATORIES LTD
`Jan 31, 2017
`AMNEAL PHARMACEUTICALS LLC
`Feb 15, 2018
`TELIGENT PHARMA INC
`Mar 3, 2017
`AKORN INC
`Aug 4, 2017
`GLENMARK PHARMACEUTICALS SA
`Aug 22, 2017
`G AND W LABORATORIES INC
`Oct 6, 2017
`CROWN LABORATORIES INC
`Dec 26, 2017
`STRIDES PHARMA GLOBAL PTE LTD
`Jan 29, 2018
`FOUGERA PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`RS PERRIGO NEW YORK INC
`Approved Prior to Jan 1, 1982
`FOUGERA PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`RS PERRIGO NEW YORK INC
`Approved Prior to Jan 1, 1982
`FOUGERA PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`RS PERRIGO NEW YORK INC
`Approved Prior to Jan 1, 1982
`ASTELLAS PHARMA US INC
`Approved Prior to Jan 1, 1982
`
`
` ASTELLAS PHARMA US INC
`
`
`
`
` Approved Prior to Jan 1, 1982
`
`ASTELLAS PHARMA US INC
`Approved Prior to Jan 1, 1982
`
`
`
` ASTELLAS PHARMA US INC
`
`
`
`
` Approved Prior to Jan 1, 1982
`
`MYLAN PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`MYLAN PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`
`
` DELCOR ASSET CORP
`
`
`
`
`
` Approved Prior to Jan 1, 1982
`
`PERRIGO UK FINCO LTD PARTNERSHIP
`Apr 13, 2015
`AKORN INC
`Dec 7, 2016
`RICONPHARMA LLC
`Sep 8, 2017
`RLD RS RANBAXY LABORATORIES LTD
`Approved Prior to Jan 1, 1982
`
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`AT
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Page 3 of 3
`
`000003
`
`