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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-four 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: | 1 |
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., McNeil Consumer Healthcare Division | 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., McNeil Consumer Healthcare Division | 16837-246 | 16837-246-50 | 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50) |
Paragraph IV (Patent) Challenges for 020958
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
PEPCID COMPLETE | TABLET, CHEWABLE;ORAL | calcium carbonate; famotidine; magnesium hydroxide | 020958 | 2004-11-01 |
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 | |||||
Patent: | Start Trial | Patent Expiration: | Feb 26, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 020958
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | Start Trial | Start Trial |
J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | Start Trial | Start Trial |
J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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