Details for New Drug Application (NDA): 091346
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The generic ingredient in VIORELE 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 091346
Tradename: | VIORELE |
Applicant: | Glenmark Generics |
Ingredient: | desogestrel; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 091346
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIORELE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091346 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-318 | 68462-318-29 | 3 BLISTER PACK in 1 CARTON (68462-318-29) / 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: | Apr 2, 2012 | TE: | AB | RLD: | No |
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