Details for New Drug Application (NDA): 206287
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NDA 206287 describes MIBELAS 24 FE, which is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. Additional details are available on the MIBELAS 24 FE profile page.
The generic ingredient in MIBELAS 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in MIBELAS 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 206287
| Tradename: | MIBELAS 24 FE |
| Applicant: | Lupin |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206287
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIBELAS 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 206287 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-911 | 68180-911-73 | 3 POUCH in 1 CARTON (68180-911-73) / 1 BLISTER PACK in 1 POUCH / 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: | May 24, 2016 | TE: | AB | RLD: | No | ||||
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