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Details for New Drug Application (NDA): 020325
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NDA 020325 describes PEPCID AC, which is a drug marketed by J And J Consumer Inc and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug. 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. Eighty-seven 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. Eighty-seven 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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