Application 076872
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | OINTMENT;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-131 | Halobetasol Propionate | Halobetasol Propionate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-131 | Halobetasol Propionate | Halobetasol Propionate | Perrigo New York Inc | ANDA | Current |
| 52959-961 | Halobetasol Propionate | Halobetasol Propionate | H.J. Harkins Company, Inc. | ANDA | Current |
| 63629-8664 | Halobetasol Propionate | Halobetasol Propionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8664 | Halobetasol Propionate | Halobetasol Propionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8664 | Halobetasol Propionate | Halobetasol Propionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8665 | Halobetasol Propionate | Halobetasol Propionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8665 | Halobetasol Propionate | Halobetasol Propionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8665 | Halobetasol Propionate | Halobetasol Propionate | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8974 | ORIG | 2004-12-30 |