Details for New Drug Application (NDA): 091346
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NDA 091346 describes VIORELE, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the VIORELE profile page.
The generic ingredient in VIORELE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in VIORELE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 091346
| Tradename: | VIORELE |
| Applicant: | Glenmark Pharms Ltd |
| 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 | A-S Medication Solutions | 50090-1395 | 50090-1395-0 | 1 KIT in 1 KIT (50090-1395-0) |
| 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 (68462-318-84) |
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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