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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 089013

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NDA 089013 describes PROMETHAZINE, which is a drug marketed by Cenci, Slate Run Pharma, Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Xttrium Labs Inc, and is included in one hundred NDAs. Additional details are available on the PROMETHAZINE profile page.

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

Summary for 089013

Tradename:	PROMETHAZINE
Applicant:	Cenci
Ingredient:	promethazine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 089013

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	6.25MG/5ML
Approval Date:	Sep 20, 1985	TE:		RLD:	No

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