Details for New Drug Application (NDA): 204848
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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 204848
Tradename: | DROSPIRENONE AND ETHINYL ESTRADIOL |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 204848
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 204848 | ANDA | A-S Medication Solutions | 50090-2494 | 50090-2494-0 | 1 KIT in 1 KIT (50090-2494-0) |
DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 204848 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-733 | 68462-733-29 | 3 BLISTER PACK in 1 CARTON (68462-733-29) / 1 KIT in 1 BLISTER PACK (68462-733-84) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 3MG;0.03MG | ||||
Approval Date: | Mar 25, 2016 | TE: | AB | RLD: | No |
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