Viewing data from:

PHENERGAN

NDA

PROMETHAZINE HYDROCHLORIDE | N010926 | PHARMOBEDIENT CONSULTING LLC

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Taro Pharmaceuticals USA, Inc. FDA-2006-P-0005 Taro Pharmaceuticals USA, Inc. filed this citizen petition on October 31, 2006, requesting that the FDA make a determination of ANDA suitability for Promethazine Hydrochloride Suppositories USP in 12.5 mg and 25 mg strengths, which were voluntarily withdrawn from sale by Wyeth for reasons other than	Other	2008-08-12	Open	Taro Pharmaceuticals USA

Source: Regulations.gov. FDA citizen petitions matched by application number.

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

5 letters from Drugs@FDA

Date	Submission	Document
Nov 15, 2004	SUPPL -30	View Letter (PDF)
Dec 26, 2002	SUPPL -17	View Letter (PDF)
Dec 26, 2002	SUPPL -22	View Letter (PDF)
Dec 26, 2002	SUPPL -20	View Letter (PDF)
Dec 26, 2002	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Approved Prior to Jan 1, 1982

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Promethazine hydrochloride (Phenergan) NDA 010926 applicant changed from Norvium Bioscience to Pharmobedient.

Old: NORVIUM BIOSCIENCE

New: PHARMOBEDIENT

MODIFIEDApplicant7/1/2026

Promethazine hydrochloride (Phenergan) NDA 010926 changed applicant from Norvium Bioscience to Pharmobedient.

Old: NORVIUM BIOSCIENCE

New: PHARMOBEDIENT

MODIFIEDApplicant Full Name7/1/2026

PHARMOBEDIENT CONSULTING LLC replaced NORVIUM BIOSCIENCE LLC as the applicant for Phenergan (promethazine hydrochloride) NDA 010926.

Old: NORVIUM BIOSCIENCE LLC

New: PHARMOBEDIENT CONSULTING LLC

MODIFIEDApplicant Full Name7/1/2026

PHARMOBEDIENT Consulting LLC replaced Norvium Bioscience LLC as the applicant for Phenergan (promethazine hydrochloride) NDA 010926.

Old: NORVIUM BIOSCIENCE LLC

New: PHARMOBEDIENT CONSULTING LLC