Details for New Drug Application (NDA): 007935

NDA 007935 describes PHENERGAN, which is a drug marketed by Wyeth Ayerst, Norvium Bioscience, Delcor Asset Corp, and Ani Pharms, and is included in six NDAs. Additional details are available on the PHENERGAN profile page.

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

Summary for 007935

Tradename:	PHENERGAN
Applicant:	Delcor Asset Corp
Ingredient:	promethazine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 007935

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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