Application 018861
- Type
- NDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | CREAM;TOPICAL | EQ 0.1% BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0168-0040 | Betamethasone Valerate | betamethasone valerate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 0168-0040 | Betamethasone Valerate | betamethasone valerate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 0168-0040 | Betamethasone Valerate | betamethasone valerate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 53002-9210 | Betamethasone Valerate | betamethasone valerate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 53002-9210 | Betamethasone Valerate | betamethasone valerate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 68071-4441 | Betamethasone Valerate | betamethasone valerate | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 68071-4441 | Betamethasone Valerate | betamethasone valerate | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 68071-4441 | Betamethasone Valerate | betamethasone valerate | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 68788-7312 | Betamethasone Valerate | betamethasone valerate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-7312 | Betamethasone Valerate | betamethasone valerate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-7312 | Betamethasone Valerate | betamethasone valerate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 70518-0721 | Betamethasone Valerate | betamethasone valerate | REMEDYREPACK INC. | NDA | Current |
| 70518-0721 | Betamethasone Valerate | betamethasone valerate | REMEDYREPACK INC. | NDA | Current |
| 70518-0721 | Betamethasone Valerate | betamethasone valerate | REMEDYREPACK INC. | NDA | Current |
| 71205-040 | Betamethasone Valerate | betamethasone valerate | Proficient Rx LP | NDA | Current |
| 71205-040 | Betamethasone Valerate | betamethasone valerate | Proficient Rx LP | NDA | Current |
| 71205-040 | Betamethasone Valerate | betamethasone valerate | Proficient Rx LP | NDA | Current |
| 71205-040 | Betamethasone Valerate | betamethasone valerate | Proficient Rx LP | NDA | Current |