Details for New Drug Application (NDA): 020801
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NDA 020801 describes PEPCID AC, which is a drug marketed by Kenvue Brands and J And J Consumer Inc and is included in three NDAs. It is available from two suppliers. Additional details are available on the PEPCID AC profile page.
The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and thirty-nine suppliers are listed for this compound. Additional details are available on the famotidine profile page.
The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and thirty-nine suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 020801
| Tradename: | PEPCID AC |
| Applicant: | Kenvue Brands |
| Ingredient: | famotidine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020801
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 24, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 17, 2007 | TE: | RLD: | Yes | |||||
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