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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

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Quagen Pharma LLC FDA-2026-P-8562 · 5 docket documents Quagen Pharma LLC filed a suitability petition requesting that the FDA determine whether certain drug substance specifications and methods are suitable for use in abbreviated new drug applications (ANDAs). The petition seeks FDA guidance on the acceptability of proposed specifications and analytical	Suitability	2026-08-04	Open	Quagen Pharma LLC
Citizen Petition from Public Citizen Health Research Group FDA-1976-N-0519 · 101 docket documents Public Citizen Health Research Group and the University of Maryland Sudden Infant Death Syndrome Institute filed this petition requesting that the FDA immediately ban all over-the-counter use of promethazine hydrochloride products including Phenergan DM and Phenergan VC, contraindicate prescription	Other	2011-03-25	Granted	Public Citizen Health Research Group
Citizens Petition from Buchanan Ingersoll FDA-2005-P-0376 · 5 docket documents Buchanan Ingersoll filed this citizen petition regarding Phenergan (promethazine HCI) tablets and suppositories. The petition requests that FDA revise the labeling to strengthen warnings about respiratory depression risks in pediatric patients and add a boxed warning highlighting the contraindicatio	Other	2009-06-04	Granted	Buchanan Ingersoll
Citizen Petition from Taro Pharmaceuticals USA, Inc. FDA-2006-P-0005 · 7 docket documents 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suitability for Promethazine Hydrochloride Suppositories USP in 12.5 mg and 25 mg strengths, which were voluntarily withdrawn from sale by Wyeth for reasons other than	Other	2008-08-12	Open	Taro Pharmaceuticals USA, Inc.

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

Clinical Trials

30 trials from ClinicalTrials.gov, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Promethazine vs. Lorazepam for Treatment of Vertigo NCT01827293	Phase 3	Completed	Shahid Beheshti University of Medical Sciences	210	2013-04 → 2013-06
A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV NCT03657810	Phase 3	Completed	Charleston Laboratories, Inc	349	2017-08-02 → 2018-11-30
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions NCT02465866	Phase 1	Completed	Charleston Laboratories, Inc	20	2014-11 → 2015-04
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects NCT01846455	Phase 4	Completed	Indivior Inc.	43	2012-09 → 2013-05
Improving Safety of Antivenom in People Bitten by Snakes NCT00270777	Phase 4	Completed	University of Kelaniya	1,000	2005-03 → 2008-04
Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery NCT01510379	N/A	Completed	Kyle A Perry	100	2011-08 → 2012-08
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels NCT02136420	Phase 4	Completed	Faisal_Karmali@MEEI.HARVARD.EDU	30	2014-06 → 2016-12
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation NCT01485692	N/A	Completed	University of Sao Paulo	120	2009-02 → 2011-03
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting NCT03639558	Phase 4	Completed	Joseph Dib	100	2018-08-28 → 2019-07-07
Sunitinib or Cediranib for Alveolar Soft Part Sarcoma NCT01391962	Phase 2	Completed	National Cancer Institute (NCI)	34	2011-07-18 → 2026-01-16

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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