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Last Updated: June 20, 2024

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 two suppliers. 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. Nineteen suppliers are listed for this compound. Additional details are available on the cimetidine profile page.
Summary for 020238
Tradename:TAGAMET HB
Applicant:Medtech Products
Formulation / Manufacturing:see details
Pharmacology for NDA: 020238
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 Prestige Brands Holdings, Inc. 52183-223 52183-223-30 3 BLISTER PACK in 1 BOX (52183-223-30) / 10 TABLET in 1 BLISTER PACK
TAGAMET HB cimetidine TABLET;ORAL 020238 NDA Medtech Products Inc. 63029-222 63029-222-01 1 BLISTER PACK in 1 BOX (63029-222-01) / 30 TABLET in 1 BLISTER PACK

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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