Application 078665
- Type
- ANDA
- Sponsor
- FDN CONSUMER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVONORGESTREL | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52959-450 | Next Choice | levonorgestrel | H.J. Harkins Company, Inc. | ANDA | Current |
| 68258-3029 | Next Choice | levonorgestrel | Dispensing Solutions, Inc. | ANDA | Current |