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PROMETHAZINE HYDROCHLORIDE PLAIN

NDA

PROMETHAZINE HYDROCHLORIDE | N008381 | ANI PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SYRUP;ORAL | Approved: Apr 18, 1984