Details for New Drug Application (NDA): 202594
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The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL 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 202594
Tradename: | DROSPIRENONE AND ETHINYL ESTRADIOL |
Applicant: | Xiromed |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 202594
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 202594 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7299 | 0378-7299-53 | 3 POUCH in 1 CARTON (0378-7299-53) / 1 BLISTER PACK in 1 POUCH (0378-7299-85) / 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: | Oct 22, 2015 | TE: | AB | RLD: | No |
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