Details for New Drug Application (NDA): 091204
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NDA 091204 describes WERA, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the WERA profile page.
The generic ingredient in WERA 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 WERA 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 091204
| Tradename: | WERA |
| Applicant: | Novast Labs Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091204
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WERA | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 091204 | ANDA | Northstar Rx LLC | 16714-370 | 16714-370-01 | 1 BLISTER PACK in 1 PACKET (16714-370-01) / 1 KIT in 1 BLISTER PACK |
| WERA | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 091204 | ANDA | Northstar Rx LLC | 16714-370 | 16714-370-02 | 1 BLISTER PACK in 1 CARTON (16714-370-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.5MG | ||||
| Approval Date: | Mar 27, 2012 | TE: | AB | RLD: | No | ||||
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