Details for New Drug Application (NDA): 020325
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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 thirty suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 020325
Tradename: | PEPCID AC |
Applicant: | J And J Consumer Inc |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020325
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 020325
Suppliers and Packaging for NDA: 020325
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEPCID AC | famotidine | TABLET;ORAL | 020325 | NDA | Johnson & Johnson Consumer Inc. | 16837-855 | 16837-855-02 | 2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH |
PEPCID AC | famotidine | TABLET;ORAL | 020325 | NDA | Johnson & Johnson Consumer Inc. | 16837-855 | 16837-855-05 | 1 BLISTER PACK in 1 CARTON (16837-855-05) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 28, 1995 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 23, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 020325
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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