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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
QuintilesIMS
AstraZeneca
Teva
Argus Health
Moodys
Chinese Patent Office
Cantor Fitzgerald
Covington

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074664

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NDA 074664 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by Dava Pharms Inc, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Ani Pharms Inc, Apotex Inc, Cycle Pharms Ltd, G And W Labs Inc, Hi Tech Pharma, Pharm Assoc, and Wockhardt Bio Ag, and is included in twenty-one NDAs. It is available from one supplier. Additional details are available on the CIMETIDINE HYDROCHLORIDE profile page.

The generic ingredient in CIMETIDINE HYDROCHLORIDE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 074664
Tradename:CIMETIDINE HYDROCHLORIDE
Applicant:Hi Tech Pharma
Ingredient:cimetidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074664
Suppliers and Packaging for NDA: 074664
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIMETIDINE HYDROCHLORIDE cimetidine hydrochloride SOLUTION;ORAL 074664 ANDA Hi-Tech Pharmacal Co., Inc. 50383-050 N 50383-050-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 300MG BASE/5ML
Approval Date:Oct 28, 1997TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cerilliant
Merck
US Army
Cantor Fitzgerald
Deloitte
Daiichi Sankyo
Argus Health
UBS

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