Viewing data from:

FLUCONAZOLE

ANDA

FLUCONAZOLE | A076077 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

4 strengths0 unique patents0 unique exclusivities

API Supply Chain15 active DMFs13 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

QUIMICA SINTETICA SAFLUCONAZOLE

DMF 89751991

INKE SAFLUCONAZOLE

DMF 147141999

MATRIX PHARMACORP PRIVATE LTDFLUCONAZOLE USP

DMF 150452000

CIPLA LTDFLUCONAZOLE USP

DMF 151612000

TARO PHARMACEUTICAL INDUSTRIES LTDFLUCONAZOLE USP

DMF 158222002

ZYDUS LIFESCIENCES LTDFLUCONAZOLE USP

DMF 162972002

DR REDDYS LABORATORIES LTDFLUCONAZOLE (FORM-2)

DMF 163162003

APITORIA PHARMA PRIVATE LTDFLUCONAZOLE USP

DMF 181762005

ALIVUS LIFE SCIENCES LTDFLUCONAZOLE USP

DMF 207342007

VIRUPAKSHA ORGANICS LTDFLUCONAZOLE USP

DMF 244372010

HENAN PURUI PHARMACEUTICAL CO LTDFLUCONAZOLE

DMF 374202022

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDFLUCONAZOLE USP

DMF 377032023

APITORIA PHARMA PRIVATE LTDFLUCONAZOLE USP (CIP PROCESS)

DMF 398762024

ATUL BIOSCIENCE LTDFLUCONAZOLE

DMF 404262024

ENDOC LIFECARE PVT LTDFLUCONAZOLE USP

DMF 424882025

CIPLA LTDInactiveFLUCONAZOLE USP

DMF 115241995

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveFLUCONAZOLE

DMF 144191999

WOCKHARDT LTDInactiveFLUCONAZOLE

DMF 148632000

GEDEON RICHTER LTDInactiveFLUCONAZOLE

DMF 158832002

CADILA PHARMACEUTICALS LTDInactiveFLUCONAZOLE

DMF 163912002

SIGNA SA DE CVInactiveFLUCONAZOLE

DMF 164202003

FDC LTDInactiveFLUCONAZOLE

DMF 166322003

GLENMARK GENERICS LTDInactiveFLUCONAZOLE

DMF 170972004

APOTECNIA SAInactiveFLUCONAZOLE

DMF 172942004

IPCA LABORATORIES LTDInactiveFLUCONAZOLE USP

DMF 209292007

GRANULES INDIA LTDInactiveFLUCONAZOLE USP

DMF 227102009

POLYDRUG LABORATORIES PVT LTDInactiveFLUCONAZOLE

DMF 234052009

IPCA LABORATORIES LTDInactiveFLUCONAZOLE USP (G3 PROCESS)

DMF 247682011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 29, 2004

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 29, 2004

#003 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 29, 2004

#004 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 29, 2004