Details for New Drug Application (NDA): 091247
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NDA 091247 describes PIMTREA, which is a drug marketed by Novast Labs and is included in one NDA. It is available from four suppliers. Additional details are available on the PIMTREA profile page.
The generic ingredient in PIMTREA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in PIMTREA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 091247
| Tradename: | PIMTREA |
| Applicant: | Novast Labs |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091247
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIMTREA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091247 | ANDA | Northstar Rx LLC | 16714-404 | 16714-404-01 | 1 BLISTER PACK in 1 PACKET (16714-404-01) / 1 KIT in 1 BLISTER PACK |
| PIMTREA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091247 | ANDA | Northstar Rx LLC | 16714-404 | 16714-404-02 | 1 BLISTER PACK in 1 CARTON (16714-404-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.15MG,N/A;0.02MG,0.01MG | ||||
| Approval Date: | Aug 1, 2013 | TE: | AB | RLD: | No | ||||
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