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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020325

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PEPCID AC (FAMOTIDINE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID AC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020325
Product Number: 001
Approval Date: Apr 28, 1995
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
PEPCID AC (FAMOTIDINE)
20MG
Marketing Status: Over-the-counter
Active Ingredient: FAMOTIDINE
Proprietary Name: PEPCID AC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020325
Product Number: 002
Approval Date: Sep 23, 2003
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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