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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019527

PEPCID (FAMOTIDINE)
40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019527
Product Number: 001
Approval Date: Feb 2, 1987
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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