Application 215689
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 20MG | No | No |
| 002 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43602-501 | FAMOTIDINE | Famotidine | Ascent Pharmaceuticals, Inc. | ANDA | Current |
| 43602-502 | FAMOTIDINE | Famotidine | Ascent Pharmaceuticals, Inc. | ANDA | Current |
| 72865-214 | FAMOTIDINE | Famotidine | XLCare Pharmaceuticals, Inc. | ANDA | Current |
| 72865-215 | FAMOTIDINE | Famotidine | XLCare Pharmaceuticals, Inc. | ANDA | Current |