Details for New Drug Application (NDA): 090721
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NDA 090721 describes FALMINA, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the FALMINA profile page.
The generic ingredient in FALMINA is ethinyl estradiol; levonorgestrel. 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; levonorgestrel profile page.
The generic ingredient in FALMINA is ethinyl estradiol; levonorgestrel. 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; levonorgestrel profile page.
Summary for 090721
| Tradename: | FALMINA |
| Applicant: | Novast Labs Ltd |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090721
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FALMINA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 090721 | ANDA | Northstar Rx LLC | 16714-359 | 16714-359-01 | 1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK |
| FALMINA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 090721 | ANDA | Northstar Rx LLC | 16714-359 | 16714-359-02 | 1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;0.1MG | ||||
| Approval Date: | Mar 28, 2012 | TE: | AB1 | RLD: | No | ||||
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