Details for New Drug Application (NDA): 090716
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NDA 090716 describes SETLAKIN, which is a drug marketed by Novast Labs and is included in one NDA. It is available from one supplier. Additional details are available on the SETLAKIN profile page.
The generic ingredient in SETLAKIN is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in SETLAKIN is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 090716
| Tradename: | SETLAKIN |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090716
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SETLAKIN | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 090716 | ANDA | Northstar Rx LLC | 16714-366 | 16714-366-03 | 3 POUCH in 1 CARTON (16714-366-03) / 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 | 0.03MG;0.15MG | ||||
| Approval Date: | Sep 15, 2014 | TE: | AB | RLD: | No | ||||
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