Application 020325
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEPCID AC | FAMOTIDINE | TABLET;ORAL | 10MG | Yes | No |
| 002 | PEPCID AC | FAMOTIDINE | TABLET;ORAL | 20MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-855 | PEPCID AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 16837-872 | Pepcid AC | Famotidine | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 66715-9748 | Pepcid AC | Famotidine | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9748 | Pepcid AC | Famotidine | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9748 | Pepcid AC | Famotidine | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9748 | Pepcid AC | Famotidine | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9748 | Pepcid AC | Famotidine | Lil' Drug Store Products, Inc. | NDA | Current |