Details for New Drug Application (NDA): 079221
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NDA 079221 describes LORYNA, 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 LORYNA profile page.
The generic ingredient in LORYNA is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
The generic ingredient in LORYNA is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 079221
| Tradename: | LORYNA |
| Applicant: | Xiromed |
| Ingredient: | drospirenone; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079221
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORYNA | drospirenone; ethinyl estradiol | TABLET;ORAL | 079221 | ANDA | Bryant Ranch Prepack | 63629-2336 | 63629-2336-1 | 3 CARTON in 1 CARTON (63629-2336-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK |
| LORYNA | drospirenone; ethinyl estradiol | TABLET;ORAL | 079221 | ANDA | Xiromed, LLC. | 70700-114 | 70700-114-85 | 3 BLISTER PACK in 1 CARTON (70700-114-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG;0.02MG | ||||
| Approval Date: | Mar 28, 2011 | TE: | AB | RLD: | No | ||||
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