Mkt.Status Active Ingredient
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`
`Proprietary Name
`DIFLUCAN
`DIFLUCAN
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`DIFLUCAN IN SODIUM CHLORIDE 0.9%
`DIFLUCAN IN SODIUM CHLORIDE 0.9%
`DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
`DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`DIFLUCAN
`DIFLUCAN
`DIFLUCAN
`DIFLUCAN
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`
`AB
`AB
`AB
`AB
`
`RLD
`RLD
`RLD
`RLD
`RLD
`RLD
`
`Strength
`Route
`Appl No Product Number Dosage Form
`50MG/5ML
`N020090 001
`FOR SUSPENSION ORAL
`200MG/5ML
`N020090 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A076246 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A076246 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A076332 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A076332 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A076918 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A076918 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A077523 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A077523 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A079150 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A079150 002
`FOR SUSPENSION ORAL
`N019950 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`N019950 006
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`N019950 002
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`N019950 004
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`N019950 003
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`N019950 005
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076304 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076304 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076145 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076087 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076145 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076087 003
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076766 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076303 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076766 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076303 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076653 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076653 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076617 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076617 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076837 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076837 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076888 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076888 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076889 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076889 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076736 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078107 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078107 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076087 002
`INJECTABLE
`INJECTION 100MG/50ML (2MG/ML)
`A079104 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A079104 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077988 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A077988 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077947 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A077947 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077909 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A077909 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A078764 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078764 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A078698 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078698 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077909 003
`INJECTABLE
`INJECTION 100MG/50ML (2MG/ML)
`N019949 001
`TABLET
`ORAL
`50MG
`N019949 002
`TABLET
`ORAL
`100MG
`N019949 003
`TABLET
`ORAL
`200MG
`N019949 004
`TABLET
`ORAL
`150MG
`A076665 001
`TABLET
`ORAL
`50MG
`A076658 001
`TABLET
`ORAL
`50MG
`A076077 001
`TABLET
`ORAL
`50MG
`A076351 001
`TABLET
`ORAL
`50MG
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Dec 23, 1993
`AB
`RLD
`PFIZER CHEMICALS DIV PFIZER INC
`Dec 23, 1993
`AB
`RLD RS PFIZER CHEMICALS DIV PFIZER INC
`AB
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`AB
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Dec 18, 2006
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Dec 18, 2006
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACSep 12, 2007
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACSep 12, 2007
`AUROBINDO PHARMA LTD
`Sep 18, 2009
`AUROBINDO PHARMA LTD
`Sep 18, 2009
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Sep 29, 1992
`PFIZER INC
`Jul 8, 1994
`RS HOSPIRA INC
`Jul 29, 2004
`RS HOSPIRA INC
`Jul 29, 2004
`FRESENIUS KABI USA LLC
`Jul 29, 2004
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`FRESENIUS KABI USA LLC
`Jul 29, 2004
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`BAXTER HEALTHCARE CORP
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`BAXTER HEALTHCARE CORP
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA
`Jan 13, 2005
`TEVA PHARMACEUTICALS USA
`Jan 13, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`HIKMA FARMACEUTICA PORTUGAL LDA
`Aug 23, 2005
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 30, 2008
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 30, 2008
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Sep 26, 2008
`RS ACS DOBFAR INFO SA
`Jul 30, 2009
`RS ACS DOBFAR INFO SA
`Jul 30, 2009
`RENAISSANCE SSA LLC
`May 26, 2010
`RENAISSANCE SSA LLC
`May 26, 2010
`BAXTER HEALTHCARE CORP
`May 26, 2010
`BAXTER HEALTHCARE CORP
`May 26, 2010
`RENAISSANCE SSA LLC
`May 26, 2010
`RENAISSANCE SSA LLC
`May 26, 2010
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`RENAISSANCE SSA LLC
`Apr 20, 2015
`PFIZER CENTRAL RESEARCH
`Jan 29, 1990
`RLD
`PFIZER CENTRAL RESEARCH
`Jan 29, 1990
`RLD
`RLD RS PFIZER CENTRAL RESEARCH
`Jan 29, 1990
`RLD
`PFIZER CENTRAL RESEARCH
`Jun 30, 1994
`APOTEX INC
`Jul 29, 2004
`DR REDDYS LABORATORIES INC
`Jul 29, 2004
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACJul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`
`Page 1 of 3
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1654
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`

`

`Mkt.Status Active Ingredient
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`DISCN
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`RX
`FLUCONAZOLE
`
`Proprietary Name
`DIFLUCAN
`DIFLUCAN
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`DIFLUCAN IN SODIUM CHLORIDE 0.9%
`DIFLUCAN IN SODIUM CHLORIDE 0.9%
`DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
`DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
`DIFLUCAN
`DIFLUCAN
`DIFLUCAN
`DIFLUCAN
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`
`AB
`AB
`AB
`AB
`
`RLD
`RLD
`RLD
`RLD
`RLD
`RLD
`
`Strength
`Route
`Appl No Product Number Dosage Form
`50MG/5ML
`N020090 001
`FOR SUSPENSION ORAL
`200MG/5ML
`N020090 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A076246 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A076246 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A076332 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A076332 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A076918 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A076918 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A077523 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A077523 002
`FOR SUSPENSION ORAL
`50MG/5ML
`A079150 001
`FOR SUSPENSION ORAL
`200MG/5ML
`A079150 002
`FOR SUSPENSION ORAL
`N019950 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`N019950 006
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`N019950 002
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`N019950 004
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`N019950 003
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`N019950 005
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076304 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076304 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076145 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076087 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076145 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076087 003
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076766 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076303 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A076766 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076303 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076653 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076653 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076617 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076617 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076837 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076837 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076888 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076888 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076889 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML)
`A076889 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML)
`A076736 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078107 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078107 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A076087 002
`INJECTABLE
`INJECTION 100MG/50ML (2MG/ML)
`A079104 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A079104 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077988 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A077988 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077947 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A077947 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077909 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A077909 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A078764 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078764 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A078698 001
`INJECTABLE
`INJECTION 200MG/100ML (2MG/ML) AP
`A078698 002
`INJECTABLE
`INJECTION 400MG/200ML (2MG/ML) AP
`A077909 003
`INJECTABLE
`INJECTION 100MG/50ML (2MG/ML)
`N019949 001
`TABLET
`ORAL
`50MG
`N019949 002
`TABLET
`ORAL
`100MG
`N019949 003
`TABLET
`ORAL
`200MG
`N019949 004
`TABLET
`ORAL
`150MG
`A076665 001
`TABLET
`ORAL
`50MG
`A076658 001
`TABLET
`ORAL
`50MG
`A076077 001
`TABLET
`ORAL
`50MG
`A076351 001
`TABLET
`ORAL
`50MG
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Dec 23, 1993
`AB
`RLD
`PFIZER CHEMICALS DIV PFIZER INC
`Dec 23, 1993
`AB
`RLD RS PFIZER CHEMICALS DIV PFIZER INC
`AB
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`AB
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Dec 18, 2006
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Dec 18, 2006
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACSep 12, 2007
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACSep 12, 2007
`AUROBINDO PHARMA LTD
`Sep 18, 2009
`AUROBINDO PHARMA LTD
`Sep 18, 2009
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Jan 29, 1990
`PFIZER INC
`Sep 29, 1992
`PFIZER INC
`Jul 8, 1994
`RS HOSPIRA INC
`Jul 29, 2004
`RS HOSPIRA INC
`Jul 29, 2004
`FRESENIUS KABI USA LLC
`Jul 29, 2004
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`FRESENIUS KABI USA LLC
`Jul 29, 2004
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 29, 2004
`BAXTER HEALTHCARE CORP
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`BAXTER HEALTHCARE CORP
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`HOSPIRA INC
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA
`Jan 13, 2005
`TEVA PHARMACEUTICALS USA
`Jan 13, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`MYLAN LABORATORIES LTD
`Mar 25, 2005
`HIKMA FARMACEUTICA PORTUGAL LDA
`Aug 23, 2005
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 30, 2008
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Jul 30, 2008
`WEST‐WARD PHARMACEUTICALS INTERNATIONA Sep 26, 2008
`RS ACS DOBFAR INFO SA
`Jul 30, 2009
`RS ACS DOBFAR INFO SA
`Jul 30, 2009
`RENAISSANCE SSA LLC
`May 26, 2010
`RENAISSANCE SSA LLC
`May 26, 2010
`BAXTER HEALTHCARE CORP
`May 26, 2010
`BAXTER HEALTHCARE CORP
`May 26, 2010
`RENAISSANCE SSA LLC
`May 26, 2010
`RENAISSANCE SSA LLC
`May 26, 2010
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`HIKMA FARMACEUTICA (PORTUGAL) SA
`Jan 30, 2012
`RENAISSANCE SSA LLC
`Apr 20, 2015
`PFIZER CENTRAL RESEARCH
`Jan 29, 1990
`RLD
`PFIZER CENTRAL RESEARCH
`Jan 29, 1990
`RLD
`RLD RS PFIZER CENTRAL RESEARCH
`Jan 29, 1990
`RLD
`PFIZER CENTRAL RESEARCH
`Jun 30, 1994
`APOTEX INC
`Jul 29, 2004
`DR REDDYS LABORATORIES INC
`Jul 29, 2004
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACJul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`
`Page 1 of 3
`
`

`

`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`DISCN
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`RX
`
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`FLUCONAZOLE
`
`A076507 001
`A074681 001
`A076665 002
`A076658 002
`A076077 002
`A076351 002
`A076507 002
`A074681 002
`A076665 003
`A076658 003
`A076077 003
`A076351 003
`A076507 003
`A074681 003
`A076665 004
`A076658 004
`A076077 004
`A076351 004
`A076507 004
`A074681 004
`A076432 001
`A076086 001
`A076042 001
`A076424 001
`A076386 001
`A076213 001
`A076432 002
`A076086 002
`A076042 002
`A076424 002
`A076386 002
`A076213 002
`A076432 003
`A076086 003
`A076042 003
`A076424 003
`A076386 003
`A076213 003
`A076432 004
`A076086 004
`A076042 004
`A076424 004
`A076386 004
`A076213 004
`A076957 001
`A076957 002
`A076957 003
`A077253 001
`A077253 002
`A077253 003
`A077253 004
`A077731 001
`A077731 002
`A077731 003
`A077731 004
`A078423 001
`A078423 002
`A078423 003
`A078423 004
`A208963 001
`A208963 002
`A208963 003
`A208963 004
`A076957 004
`
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`TABLET
`
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`ORAL
`
`50MG
`50MG
`100MG
`100MG
`100MG
`100MG
`100MG
`100MG
`150MG
`150MG
`150MG
`150MG
`150MG
`150MG
`200MG
`200MG
`200MG
`200MG
`200MG
`200MG
`50MG
`50MG
`50MG
`50MG
`50MG
`50MG
`100MG
`100MG
`100MG
`100MG
`100MG
`100MG
`150MG
`150MG
`150MG
`150MG
`150MG
`150MG
`200MG
`200MG
`200MG
`200MG
`200MG
`200MG
`50MG
`100MG
`200MG
`50MG
`100MG
`150MG
`200MG
`50MG
`100MG
`150MG
`200MG
`50MG
`100MG
`150MG
`200MG
`50MG
`100MG
`150MG
`200MG
`150MG
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`Jul 29, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA INC
`Jul 29, 2004
`APOTEX INC
`Jul 29, 2004
`DR REDDYS LABORATORIES INC
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACJul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA INC
`Jul 29, 2004
`APOTEX INC
`Jul 29, 2004
`DR REDDYS LABORATORIES INC
`Jul 29, 2004
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACJul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA INC
`Jul 29, 2004
`APOTEX INC
`Jul 29, 2004
`DR REDDYS LABORATORIES INC
`Jul 29, 2004
`IVAX PHARMACEUTICALS INC SUB TEVA PHARMACJul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`TARO PHARMACEUTICAL INDUSTRIES LTD
`Jul 29, 2004
`TEVA PHARMACEUTICALS USA INC
`Jul 29, 2004
`GEDEON RICHTER USA INC
`Jul 29, 2004
`IDT AUSTRALIA LTD
`Jul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`PLIVA INC
`Jul 29, 2004
`RANBAXY LABORATORIES LTD
`Jul 29, 2004
`ROXANE LABORATORIES INC
`Jul 29, 2004
`GEDEON RICHTER USA INC
`Jul 29, 2004
`IDT AUSTRALIA LTD
`Jul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`PLIVA INC
`Jul 29, 2004
`RANBAXY LABORATORIES LTD
`Jul 29, 2004
`ROXANE LABORATORIES INC
`Jul 29, 2004
`GEDEON RICHTER USA INC
`Jul 29, 2004
`IDT AUSTRALIA LTD
`Jul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`PLIVA INC
`Jul 29, 2004
`RANBAXY LABORATORIES LTD
`Jul 29, 2004
`ROXANE LABORATORIES INC
`Jul 29, 2004
`GEDEON RICHTER USA INC
`Jul 29, 2004
`IDT AUSTRALIA LTD
`Jul 29, 2004
`MYLAN PHARMACEUTICALS INC
`Jul 29, 2004
`PLIVA INC
`Jul 29, 2004
`RANBAXY LABORATORIES LTD
`Jul 29, 2004
`ROXANE LABORATORIES INC
`Jul 29, 2004
`UNIQUE PHARMACEUTICAL LABORATORIES A DIV Sep 28, 2005
`UNIQUE PHARMACEUTICAL LABORATORIES A DIV Sep 28, 2005
`UNIQUE PHARMACEUTICAL LABORATORIES A DIV Sep 28, 2005
`GLENMARK GENERICS LTD
`Jan 25, 2006
`GLENMARK GENERICS LTD
`Jan 25, 2006
`GLENMARK GENERICS LTD
`Jan 25, 2006
`GLENMARK GENERICS LTD
`Jan 25, 2006
`AUROBINDO PHARMA LTD
`Oct 7, 2008
`AUROBINDO PHARMA LTD
`Oct 7, 2008
`AUROBINDO PHARMA LTD
`Oct 7, 2008
`AUROBINDO PHARMA LTD
`Oct 7, 2008
`HARRIS PHARMACEUTICAL INC
`Mar 7, 2011
`HARRIS PHARMACEUTICAL INC
`Mar 7, 2011
`HARRIS PHARMACEUTICAL INC
`Mar 7, 2011
`HARRIS PHARMACEUTICAL INC
`Mar 7, 2011
`ZYDUS PHARMACEUTICALS USA INC
`Feb 16, 2017
`ZYDUS PHARMACEUTICALS USA INC
`Feb 16, 2017
`ZYDUS PHARMACEUTICALS USA INC
`Feb 16, 2017
`ZYDUS PHARMACEUTICALS USA INC
`Feb 16, 2017
`UNIQUE PHARMACEUTICAL LABORATORIES A DIV Feb 27, 2017
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`Source: "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Search results for Fluconazole." U.S. Food & Drug. Accessed on 
`November 1, 2017. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm.
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