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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020958

PEPCID COMPLETE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE)
800MG;10MG;165MG
Marketing Status: Over-the-counter
Active Ingredient: CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Proprietary Name: PEPCID COMPLETE
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 800MG;10MG;165MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020958
Product Number: 001
Approval Date: Oct 16, 2000
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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