Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020801

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PEPCID AC (FAMOTIDINE)
20MG
Marketing Status: Over-the-counter
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID AC
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020801
Product Number: 002
Approval Date: Dec 17, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
PEPCID AC (FAMOTIDINE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID AC
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020801
Product Number: 001
Approval Date: Sep 24, 1998
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Discontinued
Patent and Exclusivity Information

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