Details for New Drug Application (NDA): 020801
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The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty-four suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 020801
Tradename: | PEPCID AC |
Applicant: | J And J Consumer Inc |
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Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
Expired US Patents for NDA 020801
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | PEPCID AC | famotidine | TABLET, CHEWABLE;ORAL | 020801-001 | Sep 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET, CHEWABLE;ORAL | 020801-002 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET, CHEWABLE;ORAL | 020801-001 | Sep 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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