Details for New Drug Application (NDA): 020958
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The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 020958
Tradename: | PEPCID COMPLETE |
Applicant: | J And J Consumer Inc |
Ingredient: | calcium carbonate; famotidine; magnesium hydroxide |
Patents: | 0 |
Pharmacology for NDA: 020958
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 020958
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958 | NDA | Johnson & Johnson Consumer Inc. | 16837-246 | 16837-246-25 | 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25) |
PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958 | NDA | Johnson & Johnson Consumer Inc. | 16837-246 | 16837-246-50 | 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 800MG;10MG;165MG | ||||
Approval Date: | Oct 16, 2000 | TE: | RLD: | Yes |
Expired US Patents for NDA 020958
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