Application 078324
- Type
- ANDA
- Sponsor
- BRECKENRIDGE PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL | 1MG;0.5MG | No | No |
| 002 | ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL | 0.5MG;0.1MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |