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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216446

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NDA 216446 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 216446

Tradename:	PROMETHAZINE HYDROCHLORIDE
Applicant:	Annora Pharma
Ingredient:	promethazine hydrochloride
Patents:	0

Pharmacology for NDA: 216446

Medical Subject Heading (MeSH) Categories for 216446

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Suppliers and Packaging for NDA: 216446

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	216446	ANDA	Camber Pharmaceuticals, Inc.	31722-040	31722-040-31	2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACK
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	216446	ANDA	Camber Pharmaceuticals, Inc.	31722-041	31722-041-31	2 BLISTER PACK in 1 CARTON (31722-041-31) / 6 SUPPOSITORY in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	12.5MG
Approval Date:	Nov 2, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	25MG
Approval Date:	Nov 2, 2022	TE:	AB	RLD:	No

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