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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson
Argus Health

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087165

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NDA 087165 describes PROMETHEGAN, which is a drug marketed by G And W Labs and is included in one NDA. It is available from four suppliers. Additional details are available on the PROMETHEGAN profile page.

The generic ingredient in PROMETHEGAN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 087165
Applicant:G And W Labs
Ingredient:promethazine hydrochloride
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087165
Medical Subject Heading (MeSH) Categories for 087165
Suppliers and Packaging for NDA: 087165
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHEGAN promethazine hydrochloride SUPPOSITORY;RECTAL 087165 ANDA G&W Laboratories, Inc. 0713-0132 N 0713-0132-12
PROMETHEGAN promethazine hydrochloride SUPPOSITORY;RECTAL 087165 ANDA G&W Laboratories, Inc. 0713-0132 N 0713-0132-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength50MG
Approval Date:Aug 14, 1987TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Fish and Richardson

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