Application 018865
- 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 | OINTMENT;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 |
|---|
| 0168-0033 | Betamethasone Valerate | betamethasone valerate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 0168-0033 | Betamethasone Valerate | betamethasone valerate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 0168-0033 | Betamethasone Valerate | betamethasone valerate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 21695-586 | Betamethasone Valerate | betamethasone valerate | Rebel Distributors Corp | ANDA | Current |
| 50090-0165 | Betamethasone Valerate | betamethasone valerate | A-S Medication Solutions | NDA | Current |
| 68788-7095 | Betamethasone Valerate | betamethasone valerate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-7095 | Betamethasone Valerate | betamethasone valerate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-7095 | Betamethasone Valerate | betamethasone valerate | Preferred Pharmaceuticals Inc. | NDA | Current |