Application 075840
- Type
- ANDA
- Sponsor
- DURAMED PHARMS BARR
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-21 | 0.03MG;0.3MG | No | No |
| 002 | CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-28 | 0.03MG;0.3MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 50090-2183 | Cryselle | Norgestrel and Ethinyl Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-2183 | Cryselle | Norgestrel and Ethinyl Estradiol | A-S Medication Solutions | ANDA | Current |
| 53002-1188 | Cryselle | Norgestrel and Ethinyl Estradiol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1214 | Cryselle | Norgestrel and Ethinyl Estradiol | REMEDYREPACK INC. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 8804 | ORIG | 2003-04-15 |