Details for New Drug Application (NDA): 090948
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NDA 090948 describes DASETTA 1/35, 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 DASETTA 1/35 profile page.
The generic ingredient in DASETTA 1/35 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in DASETTA 1/35 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 090948
| Tradename: | DASETTA 1/35 |
| Applicant: | Novast Labs Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090948
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DASETTA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090948 | ANDA | Northstar Rx LLC | 16714-348 | 16714-348-01 | 1 BLISTER PACK in 1 PACKET (16714-348-01) / 1 KIT in 1 BLISTER PACK |
| DASETTA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090948 | ANDA | Northstar Rx LLC | 16714-348 | 16714-348-02 | 1 BLISTER PACK in 1 CARTON (16714-348-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG | ||||
| Approval Date: | Dec 22, 2011 | TE: | AB | RLD: | No | ||||
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