Details for New Drug Application (NDA): 020958
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NDA 020958 describes PEPCID COMPLETE, which is a drug marketed by Kenvue Brands and is included in one NDA. It is available from six suppliers. 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-five 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-five 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: | Kenvue Brands |
| 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 | Kenvue Brands LLC | 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 | Kenvue Brands LLC | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kenvue Brands | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | 4,283,408*PED | ⤷ Get Started Free |
| Kenvue Brands | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | 6,814,978*PED | ⤷ Get Started Free |
| Kenvue Brands | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | 5,817,340*PED | ⤷ Get Started Free |
| Kenvue Brands | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | 5,989,588*PED | ⤷ Get Started Free |
| Kenvue Brands | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | 5,229,137*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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