Application 040114
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTRADIOL | ESTRADIOL | TABLET;ORAL | 1MG | No | No |
| 002 | ESTRADIOL | ESTRADIOL | TABLET;ORAL | 2MG | No | No |
| 003 | ESTRADIOL | ESTRADIOL | TABLET;ORAL | 0.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-069 | Estradiol | Estradiol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-070 | Estradiol | Estradiol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-613 | Estradiol | Estradiol | Rebel Distributors Corp | ANDA | Current |
| 21695-623 | Estradiol | Estradiol | Rebel Distributors Corp | ANDA | Current |
| 50090-1343 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 55700-114 | Estradiol | Estradiol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-482 | Estradiol | Estradiol | Proficient Rx LP | ANDA | Current |
| 63629-5208 | Estradiol | Estradiol | Bryant Ranch Prepack | ANDA | Current |
| 64205-048 | Estradiol | Estradiol | ReadyMeds | ANDA | Current |
| 64205-488 | Estradiol | Estradiol | ReadyMeds | ANDA | Current |
| 68788-9416 | Estradiol | Estradiol | Preferred Pharmaceuticals, Inc. | ANDA | Current |