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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Boehringer Ingelheim
US Department of Justice

Generated: December 17, 2017

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-eight suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.

Summary for 087165

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 0713-0132-12 12 SUPPOSITORY in 1 BOX (0713-0132-12)
PROMETHEGAN promethazine hydrochloride SUPPOSITORY;RECTAL 087165 ANDA G&W Laboratories, Inc. 0713-0132 0713-0132-10 1000 SUPPOSITORY in 1 BOX (0713-0132-10)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Boehringer Ingelheim
US Department of Justice

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