Viewing data from:

KETOCONAZOLE

ANDA

KETOCONAZOLE | A076942 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs8 inactive

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

JANSSEN PHARMACEUTICA NVKETOCONAZOLE DRUG SUBSTANCE

DMF 100371993

QUIMICA SINTETICA SAKETOCONAZOLE

DMF 120231996

DERIVADOS QUIMICOS SAUKETOCONAZOLE

DMF 147942001

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)KETOCONAZOLE

DMF 162122002

PIRAMAL PHARMA LTDKETOCONAZOLE

DMF 172902004

SHARON BIO MEDICINE LTDKETOCONAZOLE USP

DMF 250132011

SS PHARMA LLCKETOCONAZOLE USP

DMF 384172023

QUIMICA SINTETICA SAInactiveKETOCONAZOLE

DMF 97181992

ESTEVE QUIMICA SAInactiveKETOCONAZOLE

DMF 115791995

ALBEMARLE CORPInactiveKETOCONAZOLE

DMF 121711996

QUIMICA FINA FARMEX SA DE CVInactiveKETOCONAZOLE

DMF 127941997

NAPP TECHNOLOGIES INCInactiveKETOCONAZOLE USP

DMF 149482000

RECORDATI ESPANA SLInactiveKETOCONAZOLE

DMF 159602002

FDC LTDInactiveKETOCONAZOLE

DMF 168022003

GUFIC BIOSCIENCES LTDInactiveKETOCONAZOLE USP

DMF 169152003

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

Products (1)

#001 — 2%

0 patents0 exclusivities▴

SHAMPOO;TOPICAL | Approved: Apr 11, 2005

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its corporate name from Cosette to Cosette Pharms NC for NDA 076942 (ketoconazole).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for Ketoconazole NDA 076942.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC