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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 084591

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NDA 084591 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt Bio Ag, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Sun Pharma Canada, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Pharm Assoc, Quagen, Strides Pharma, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Pharmobedient, and Ani Pharms, and is included in ninety NDAs. It is available from forty-eight suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for 084591

Tradename:	PROMETHAZINE HYDROCHLORIDE
Applicant:	Watson Labs
Ingredient:	promethazine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084591

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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