Application 078337
- Type
- ANDA
- Sponsor
- PERRIGO UK FINCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | AEROSOL, FOAM;TOPICAL | 0.12% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-053 | Betamethasone Valerate | Betamethasone Valerate | Perrigo New York Inc | ANDA | Current |
| 45802-053 | Betamethasone Valerate | Betamethasone Valerate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-053 | Betamethasone Valerate | Betamethasone Valerate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-053 | Betamethasone Valerate | Betamethasone Valerate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9146 | ORIG | 2012-11-28 |