Details for New Drug Application (NDA): 091398
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NDA 091398 describes BLISOVI 24 FE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the BLISOVI 24 FE profile page.
The generic ingredient in BLISOVI 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in BLISOVI 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 091398
| Tradename: | BLISOVI 24 FE |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091398
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BLISOVI 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 091398 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-864 | 68180-864-73 | 3 BLISTER PACK in 1 CARTON (68180-864-73) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;1MG | ||||
| Approval Date: | Oct 28, 2015 | TE: | AB | RLD: | No | ||||
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