Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
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ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xiromed | GEMMILY | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 213317 | ANDA | Xiromed, LLC | 70700-152-85 | 3 CARTON in 1 CARTON (70700-152-85) / 1 BLISTER PACK in 1 CARTON (70700-152-84) / 1 KIT in 1 BLISTER PACK | 2020-11-09 |
| Amneal Pharms | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 214292 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1686-3 | 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK | 2021-07-26 |
| Glenmark Pharms Ltd | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 213418 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-849-29 | 3 CARTON in 1 BOX (68462-849-29) / 1 BLISTER PACK in 1 CARTON (68462-849-84) / 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40) * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40) | 2022-07-27 |
| Apil | TAYTULLA | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 204426 | NDA | Allergan, Inc. | 0023-5862-29 | 1 BLISTER PACK in 1 CARTON (0023-5862-29) / 1 KIT in 1 BLISTER PACK | 2016-05-01 |
| Apil | TAYTULLA | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 204426 | NDA | Allergan, Inc. | 0023-5862-30 | 5 CARTON in 1 TRAY (0023-5862-30) / 1 BLISTER PACK in 1 CARTON (0023-5862-28) / 1 KIT in 1 BLISTER PACK | 2016-05-01 |
| Apil | TAYTULLA | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 204426 | NDA | Allergan, Inc. | 0023-5862-31 | 6 CARTON in 1 TRAY (0023-5862-31) / 6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2016-05-01 |
| Millicent Pr | FEMLYV | ethinyl estradiol; norethindrone acetate | TABLET, ORALLY DISINTEGRATING;ORAL | 218718 | NDA | Millicent US, Inc. | 72495-601-28 | 1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 2024-11-01 |
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