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PROMETHAZINE HYDROCHLORIDE

ANDA

PROMETHAZINE HYDROCHLORIDE | A040428 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs5 inactive

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

ZYDUS LIFESCIENCES LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 198402006

EMCURE PHARMACEUTICALS LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 258062012

AREVA SYNTHETICS LLCPROMETHAZINE HYDROCHLORIDE USP

DMF 421762025

PHENCHEM INDUSTRIES LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 19741972

MAY AND BAKER LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 94051991

SIGMA ALDRICH IRELAND LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 118881996

WANBURY LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 181732005

IPCA LABORATORIES LTDInactivePROMETHAZINE HYDROCHLORIDE USP

DMF 272412013

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

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Feb 5, 2002

No patent or exclusivity listings for this strength.

#002 — 12.5MG

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Mar 31, 2003

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals NC assumed applicant responsibility for the promethazine hydrochloride NDA 040428.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for the promethazine hydrochloride NDA 040428.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC