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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. Ninety-three 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 |
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., McNeil Consumer Healthcare Division | 16837-855 | 16837-855-05 | 1 BLISTER PACK in 1 CARTON (16837-855-05) > 5 TABLET, FILM COATED in 1 BLISTER PACK |
PEPCID AC | famotidine | TABLET;ORAL | 020325 | NDA | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | 16837-855 | 16837-855-09 | 1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
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 | Start Trial | Start Trial |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | Start Trial | Start Trial |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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