Application 065112
- Type
- ANDA
- Sponsor
- TOLMAR
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYTHROMYCIN AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; ERYTHROMYCIN | GEL;TOPICAL | 5%;3% | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-7054 | Erythromycin and Benzoyl Peroxide | Erythromycin and Benzoyl Peroxide | Sandoz Inc. | ANDA | Current |
| 0781-7054 | Erythromycin and Benzoyl Peroxide | Erythromycin and Benzoyl Peroxide | Sandoz Inc. | ANDA | Current |
| 0781-7094 | Erythromycin and Benzoyl Peroxide | Erythromycin and Benzoyl Peroxide | Sandoz Inc. | ANDA | Current |
| 0781-7094 | Erythromycin and Benzoyl Peroxide | Erythromycin and Benzoyl Peroxide | Sandoz Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 42809 | ORIG | 2007-07-06 |