Application 078162
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | CREAM;TOPICAL | 0.05% | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0640 | Halobetasol Propionate | Halobetasol Propionate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0640 | Halobetasol Propionate | Halobetasol Propionate | G&W Laboratories, Inc. | ANDA | Current |
| 0713-0640 | Halobetasol Propionate | Halobetasol Propionate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0640 | Halobetasol Propionate | Halobetasol Propionate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 42254-250 | Halobetasol Propionate | Halobetasol Propionate | Rebel Distributors Corp | ANDA | Current |