Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020238

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TAGAMET HB (CIMETIDINE)
200MG
Marketing Status: Over-the-counter

Active Ingredient: CIMETIDINE
Proprietary Name: TAGAMET HB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020238
Product Number: 002
Approval Date: Aug 21, 1996
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

TAGAMET HB (CIMETIDINE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CIMETIDINE
Proprietary Name: TAGAMET HB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020238
Product Number: 001
Approval Date: Jun 19, 1995
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information