FDA Orange Book - Loratadine Desloratadine
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`LORATADINE
`OTC
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`LORATADINE
`OTC
`DISCN
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`DISCN
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`DISCN
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`DISCN
`LORATADINE
`DISCN
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE; PSEUDOEPHEDRINE SULFATE
`RX
`DESLORATADINE; PSEUDOEPHEDRINE SULFATE
`RX
`DESLORATADINE; PSEUDOEPHEDRINE SULFATE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Route Strength
`Proprietary Name
`N019658 002
`TABLET
`ORAL 10MG
`CLARITIN
`A075209 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076134 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076154 001
`TABLET
`ORAL 10MG
`LORATADINE
`N019658 003
`TABLET
`ORAL 10MG
`CLARITIN HIVES RELIEF
`N021512 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076301 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076471 001
`TABLET
`ORAL 10MG
`LORATADINE
`A075790 001
`TABLET
`ORAL 10MG
`LORATADINE
`A078447 001
`TABLET
`ORAL 10MG
`LORATADINE
`N019670 002
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 120MG
`CLARITIN-D
`N020470 002
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`CLARITIN-D 24 HOUR
`LORATADINE AND PSEUDOEPHEDA076050 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 120MG
`LORATADINE AND PSEUDOEPHEDA075706 001
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`LORATADINE AND PSEUDOEPHEDA076208 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 120MG
`LORATADINE AND PSEUDOEPHEDA075989 001
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`LORATADINE AND PSEUDOEPHEDA076557 001
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`CLARITIN REDITABS
`N020704 002
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`ALAVERT
`N021375 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`LORATADINE
`A075822 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`LORATADINE
`A076011 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`LORATADINE
`A075990 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`CLARITIN HIVES RELIEF REDITAB N020704 003
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`CLARITIN REDITABS
`N021993 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 5MG
`LORATADINE REDIDOSE
`A077153 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`CHILDREN'S CLARITIN
`N021891 001
`TABLET, CHEWABLE
`ORAL 5MG
`CLARITIN
`N020641 002
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A075505 001
`SYRUP
`ORAL 1MG/ML
`CLARITIN HIVES RELIEF
`N020641 003
`SYRUP
`ORAL 1MG/ML **Federal Register RLD
`LORATADINE
`A075728 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A076805 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A075815 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A076529 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A075565 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A077421 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A201865 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`N021734 001
`SUSPENSION
`ORAL 1MG/ML
`CLARITIN
`N021952 001
`CAPSULE
`ORAL 10MG
`LORATADINE
`A206214 001
`CAPSULE
`ORAL 10MG
`CLARINEX
`N021165 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078357 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078352 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078359 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078364 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078365 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078361 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078351 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078355 001
`TABLET
`ORAL 5MG
`CLARINEX D 24 HOUR
`N021605 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 240MG
`CLARINEX-D 12 HOUR
`N021313 001
`TABLET, EXTENDED RELEASE
`ORAL 2.5MG; 120MG
`DESLORATADINE AND PSEUDOEPA078366 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 240MG
`CLARINEX
`N021300 001
`SOLUTION
`ORAL 0.5MG/ML
`DESLORATADINE
`A202592 001
`SOLUTION
`ORAL 0.5MG/ML
`DESLORATADINE
`A202936 001
`SOLUTION
`ORAL 0.5MG/ML
`CLARINEX
`N021312 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 5MG
`CLARINEX
`N021312 002
`TABLET, ORALLY DISINTEGRATING
`ORAL 2.5MG
`DESLORATADINE
`A078367 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 2.5MG
`DESLORATADINE
`A078367 002
`TABLET, ORALLY DISINTEGRATING
`ORAL 5MG
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Nov 27, 2002
`RLD RS BAYER HEALTHCARE LLC
`Jan 21, 2003
`SANDOZ INC
`Aug 18, 2003
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Aug 20, 2003
`MYLAN PHARMACEUTICALS INC
`Nov 19, 2003
`RLD RS BAYER HEALTHCARE LLC
`Jun 24, 2004
`PERRIGO CO
`Jun 25, 2004
`L PERRIGO CO
`Feb 14, 2006
`APOTEX INC ETOBICOKE SITE
`Nov 7, 2008
`MYLAN PHARMACEUTICALS INC
`Aug 12, 2011
`MYLAN PHARMACEUTICALS INC
`Nov 27, 2002
`RLD RS BAYER HEALTHCARE LLC
`Nov 27, 2002
`RLD RS BAYER HEALTHCARE LLC
`Jan 30, 2003
`PERRIGO PHARMA INTERNATIONAL DAC
`Feb 21, 2003
`ACTAVIS LABORATORIES FL INC
`Jan 28, 2004
`ACTAVIS LABORATORIES FL INC
`PERRIGO PHARMA INTERNATIONAL DAC Mar 4, 2004
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Sep 22, 2004
`RLD RS BAYER HEALTHCARE LLC
`Nov 27, 2002
`PFIZER INC
`Dec 19, 2002
`PFIZER INC
`Feb 10, 2003
`PERRIGO PHARMA INTERNATIONAL DAC
`Sep 29, 2003
`ACTAVIS LABORATORIES FL INC
`Nov 3, 2003
`RLD RS BAYER HEALTHCARE LLC
`Nov 19, 2003
`RLD RS BAYER HEALTHCARE LLC
`Dec 12, 2006
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Apr 11, 2007
`RLD RS BAYER HEALTHCARE LLC
`Aug 23, 2006
`RLD RS BAYER HEALTHCARE LLC
`Nov 27, 2002
`TEVA PHARMACEUTICALS USA INC
`Nov 7, 2003
`BAYER HEALTHCARE LLC
`Nov 19, 2003
`L PERRIGO CO
`Aug 20, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD Aug 20, 2004
`WOCKHARDT BIO AG
`Aug 20, 2004
`RANBAXY LABORATORIES LTD
`Aug 20, 2004
`APOTEX INC
`Oct 5, 2004
`SILARX PHARMACEUTICALS INC
`Jun 29, 2006
`TARO PHARMACEUTICAL INDUSTRIES LTD Jul 31, 2015
`RLD RS TARO PHARMACEUTICALS USA INC
`Oct 4, 2005
`RLD RS BAYER HEALTHCARE LLC
`Jun 16, 2008
`MARKSANS PHARMA LTD
`Sep 23, 2016
`RLD RS MERCK SHARP AND DOHME CORP
`Dec 21, 2001
`ORCHID HEALTHCARE
`Feb 19, 2010
`LUPIN PHARMACEUTICALS INC
`Oct 25, 2010
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Nov 16, 2010
`SANDOZ INC
`Dec 3, 2010
`DR REDDYS LABORATORIES LTD
`Mar 8, 2011
`PERRIGO R AND D CO
`Dec 22, 2011
`MYLAN PHARMACEUTICALS INC
`Feb 10, 2012
`BELCHER PHARMACEUTICALS LLC
`Apr 19, 2012
`RLD RS MERCK SHARP AND DOHME CORP
`Mar 3, 2005
`RLD RS MERCK SHARP AND DOHME CORP
`Feb 1, 2006
`DR REDDYS LABORATORIES LTD
`Apr 26, 2011
`RLD RS MERCK SHARP AND DOHME CORP
`Sep 1, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD Jun 30, 2015
`TARO PHARMACEUTICAL INDUSTRIES LTD May 26, 2016
`RLD RS MERCK SHARP AND DOHME CORP
`Jun 26, 2002
`RLD
`MERCK SHARP AND DOHME CORP
`Jul 14, 2005
`DOCTOR REDDYS LABORATORIES LTD
`Jul 12, 2010
`DOCTOR REDDYS LABORATORIES LTD
`Jul 12, 2010
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`AB
`AA
`AA
`AA
`AB
`AB
`AB
`AB
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Exhibit 1064
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`LORATADINE
`OTC
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`LORATADINE
`OTC
`DISCN
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`DISCN
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE; PSEUDOEPHEDRINE SULFATE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`DISCN
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`DISCN
`LORATADINE
`DISCN
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`OTC
`LORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE; PSEUDOEPHEDRINE SULFATE
`RX
`DESLORATADINE; PSEUDOEPHEDRINE SULFATE
`RX
`DESLORATADINE; PSEUDOEPHEDRINE SULFATE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`RX
`DESLORATADINE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Route Strength
`Proprietary Name
`N019658 002
`TABLET
`ORAL 10MG
`CLARITIN
`A075209 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076134 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076154 001
`TABLET
`ORAL 10MG
`LORATADINE
`N019658 003
`TABLET
`ORAL 10MG
`CLARITIN HIVES RELIEF
`N021512 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076301 001
`TABLET
`ORAL 10MG
`LORATADINE
`A076471 001
`TABLET
`ORAL 10MG
`LORATADINE
`A075790 001
`TABLET
`ORAL 10MG
`LORATADINE
`A078447 001
`TABLET
`ORAL 10MG
`LORATADINE
`N019670 002
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 120MG
`CLARITIN-D
`N020470 002
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`CLARITIN-D 24 HOUR
`LORATADINE AND PSEUDOEPHEDA076050 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 120MG
`LORATADINE AND PSEUDOEPHEDA075706 001
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`LORATADINE AND PSEUDOEPHEDA076208 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 120MG
`LORATADINE AND PSEUDOEPHEDA075989 001
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`LORATADINE AND PSEUDOEPHEDA076557 001
`TABLET, EXTENDED RELEASE
`ORAL 10MG; 240MG
`CLARITIN REDITABS
`N020704 002
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`ALAVERT
`N021375 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`LORATADINE
`A075822 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`LORATADINE
`A076011 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`LORATADINE
`A075990 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`CLARITIN HIVES RELIEF REDITAB N020704 003
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`CLARITIN REDITABS
`N021993 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 5MG
`LORATADINE REDIDOSE
`A077153 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 10MG
`CHILDREN'S CLARITIN
`N021891 001
`TABLET, CHEWABLE
`ORAL 5MG
`CLARITIN
`N020641 002
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A075505 001
`SYRUP
`ORAL 1MG/ML
`CLARITIN HIVES RELIEF
`N020641 003
`SYRUP
`ORAL 1MG/ML **Federal Register RLD
`LORATADINE
`A075728 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A076805 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A075815 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A076529 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A075565 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A077421 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`A201865 001
`SYRUP
`ORAL 1MG/ML
`LORATADINE
`N021734 001
`SUSPENSION
`ORAL 1MG/ML
`CLARITIN
`N021952 001
`CAPSULE
`ORAL 10MG
`LORATADINE
`A206214 001
`CAPSULE
`ORAL 10MG
`CLARINEX
`N021165 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078357 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078352 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078359 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078364 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078365 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078361 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078351 001
`TABLET
`ORAL 5MG
`DESLORATADINE
`A078355 001
`TABLET
`ORAL 5MG
`CLARINEX D 24 HOUR
`N021605 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 240MG
`CLARINEX-D 12 HOUR
`N021313 001
`TABLET, EXTENDED RELEASE
`ORAL 2.5MG; 120MG
`DESLORATADINE AND PSEUDOEPA078366 001
`TABLET, EXTENDED RELEASE
`ORAL 5MG; 240MG
`CLARINEX
`N021300 001
`SOLUTION
`ORAL 0.5MG/ML
`DESLORATADINE
`A202592 001
`SOLUTION
`ORAL 0.5MG/ML
`DESLORATADINE
`A202936 001
`SOLUTION
`ORAL 0.5MG/ML
`CLARINEX
`N021312 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 5MG
`CLARINEX
`N021312 002
`TABLET, ORALLY DISINTEGRATING
`ORAL 2.5MG
`DESLORATADINE
`A078367 001
`TABLET, ORALLY DISINTEGRATING
`ORAL 2.5MG
`DESLORATADINE
`A078367 002
`TABLET, ORALLY DISINTEGRATING
`ORAL 5MG
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Nov 27, 2002
`RLD RS BAYER HEALTHCARE LLC
`Jan 21, 2003
`SANDOZ INC
`Aug 18, 2003
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Aug 20, 2003
`MYLAN PHARMACEUTICALS INC
`Nov 19, 2003
`RLD RS BAYER HEALTHCARE LLC
`Jun 24, 2004
`PERRIGO CO
`Jun 25, 2004
`L PERRIGO CO
`Feb 14, 2006
`APOTEX INC ETOBICOKE SITE
`Nov 7, 2008
`MYLAN PHARMACEUTICALS INC
`Aug 12, 2011
`MYLAN PHARMACEUTICALS INC
`Nov 27, 2002
`RLD RS BAYER HEALTHCARE LLC
`Nov 27, 2002
`RLD RS BAYER HEALTHCARE LLC
`Jan 30, 2003
`PERRIGO PHARMA INTERNATIONAL DAC
`Feb 21, 2003
`ACTAVIS LABORATORIES FL INC
`Jan 28, 2004
`ACTAVIS LABORATORIES FL INC
`PERRIGO PHARMA INTERNATIONAL DAC Mar 4, 2004
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Sep 22, 2004
`RLD RS BAYER HEALTHCARE LLC
`Nov 27, 2002
`PFIZER INC
`Dec 19, 2002
`PFIZER INC
`Feb 10, 2003
`PERRIGO PHARMA INTERNATIONAL DAC
`Sep 29, 2003
`ACTAVIS LABORATORIES FL INC
`Nov 3, 2003
`RLD RS BAYER HEALTHCARE LLC
`Nov 19, 2003
`RLD RS BAYER HEALTHCARE LLC
`Dec 12, 2006
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Apr 11, 2007
`RLD RS BAYER HEALTHCARE LLC
`Aug 23, 2006
`RLD RS BAYER HEALTHCARE LLC
`Nov 27, 2002
`TEVA PHARMACEUTICALS USA INC
`Nov 7, 2003
`BAYER HEALTHCARE LLC
`Nov 19, 2003
`L PERRIGO CO
`Aug 20, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD Aug 20, 2004
`WOCKHARDT BIO AG
`Aug 20, 2004
`RANBAXY LABORATORIES LTD
`Aug 20, 2004
`APOTEX INC
`Oct 5, 2004
`SILARX PHARMACEUTICALS INC
`Jun 29, 2006
`TARO PHARMACEUTICAL INDUSTRIES LTD Jul 31, 2015
`RLD RS TARO PHARMACEUTICALS USA INC
`Oct 4, 2005
`RLD RS BAYER HEALTHCARE LLC
`Jun 16, 2008
`MARKSANS PHARMA LTD
`Sep 23, 2016
`RLD RS MERCK SHARP AND DOHME CORP
`Dec 21, 2001
`ORCHID HEALTHCARE
`Feb 19, 2010
`LUPIN PHARMACEUTICALS INC
`Oct 25, 2010
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Nov 16, 2010
`SANDOZ INC
`Dec 3, 2010
`DR REDDYS LABORATORIES LTD
`Mar 8, 2011
`PERRIGO R AND D CO
`Dec 22, 2011
`MYLAN PHARMACEUTICALS INC
`Feb 10, 2012
`BELCHER PHARMACEUTICALS LLC
`Apr 19, 2012
`RLD RS MERCK SHARP AND DOHME CORP
`Mar 3, 2005
`RLD RS MERCK SHARP AND DOHME CORP
`Feb 1, 2006
`DR REDDYS LABORATORIES LTD
`Apr 26, 2011
`RLD RS MERCK SHARP AND DOHME CORP
`Sep 1, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD Jun 30, 2015
`TARO PHARMACEUTICAL INDUSTRIES LTD May 26, 2016
`RLD RS MERCK SHARP AND DOHME CORP
`Jun 26, 2002
`RLD
`MERCK SHARP AND DOHME CORP
`Jul 14, 2005
`DOCTOR REDDYS LABORATORIES LTD
`Jul 12, 2010
`DOCTOR REDDYS LABORATORIES LTD
`Jul 12, 2010
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`AB
`AA
`AA
`AA
`AB
`AB
`AB
`AB
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Exhibit 1064
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
