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Covington
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US Department of Justice
Cipla
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020238

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NDA 020238 describes TAGAMET HB, which is a drug marketed by Medtech Products and Glaxosmithkline and is included in two NDAs. It is available from one supplier. Additional details are available on the TAGAMET HB profile page.

The generic ingredient in TAGAMET HB is cimetidine. There are twenty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cimetidine profile page.
Summary for 020238
Tradename:TAGAMET HB
Applicant:Medtech Products
Ingredient:cimetidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020238
Suppliers and Packaging for NDA: 020238
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAGAMET HB cimetidine TABLET;ORAL 020238 NDA Medtech Products Inc. 63029-222 N 63029-222-01
TAGAMET HB cimetidine TABLET;ORAL 020238 NDA Medtech Products Inc. 63029-222 N 63029-222-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 19, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Aug 21, 1996TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Federal Trade Commission
QuintilesIMS
McKinsey
Cantor Fitzgerald
Harvard Business School
Express Scripts
AstraZeneca

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