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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 083312

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NDA 083312 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, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Rising, 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-five 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 083312

Tradename:	PROMETHAZINE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	promethazine hydrochloride
Patents:	0

Pharmacology for NDA: 083312

Medical Subject Heading (MeSH) Categories for 083312

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Suppliers and Packaging for NDA: 083312

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	INJECTABLE;INJECTION	083312	ANDA	Henry Schein, Inc.	0404-9940	0404-9940-01	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01) / 1 mL in 1 VIAL, SINGLE-DOSE
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	INJECTABLE;INJECTION	083312	ANDA	Henry Schein, Inc.	0404-9941	0404-9941-01	1 AMPULE in 1 BAG (0404-9941-01) / 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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