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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
Moodys
Accenture
UBS
Daiichi Sankyo
Chinese Patent Office
Novartis
Harvard Business School
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040027

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NDA 040027 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Hi Tech Pharma, and Tris Pharma Inc, and is included in four NDAs. It is available from two suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Pharmacology for NDA: 040027
Suppliers and Packaging for NDA: 040027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040027 ANDA Hi-Tech Pharmacal Co., Inc. 50383-803 50383-803-16 473 mL in 1 BOTTLE (50383-803-16)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040027 ANDA Hi-Tech Pharmacal Co., Inc. 50383-803 50383-803-08 237 mL in 1 BOTTLE (50383-803-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Jul 31, 1996TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Dow
Boehringer Ingelheim
Citi
McKinsey
Daiichi Sankyo
Novartis
Healthtrust
Argus Health

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