Details for New Drug Application (NDA): 202689
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NDA 202689 describes VOLNEA, which is a drug marketed by Xiromed and is included in one NDA. It is available from two suppliers. Additional details are available on the VOLNEA profile page.
The generic ingredient in VOLNEA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in VOLNEA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 202689
| Tradename: | VOLNEA |
| Applicant: | Xiromed |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202689
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOLNEA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202689 | ANDA | Bryant Ranch Prepack | 63629-2449 | 63629-2449-1 | 3 BLISTER PACK in 1 CARTON (63629-2449-1) / 1 KIT in 1 BLISTER PACK |
| VOLNEA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202689 | ANDA | Xiromed, LLC. | 70700-122 | 70700-122-85 | 3 CARTON in 1 CARTON (70700-122-85) / 1 BLISTER PACK in 1 CARTON (70700-122-84) / 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: | Sep 9, 2016 | TE: | AB | RLD: | No | ||||
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