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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Cantor Fitzgerald
Queensland Health

Generated: December 14, 2017

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

Summary for 020238

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 63029-222-03 1 BLISTER PACK in 1 BOX (63029-222-03) > 50 TABLET in 1 BLISTER PACK
TAGAMET HB cimetidine TABLET;ORAL 020238 NDA Medtech Products Inc. 63029-222 63029-222-02 1 BLISTER PACK in 1 BOX (63029-222-02) > 6 TABLET in 1 BLISTER PACK

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice

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