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Details for New Drug Application (NDA): 020958
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NDA 020958 describes PEPCID COMPLETE, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PEPCID COMPLETE profile page.
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.
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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