Details for New Drug Application (NDA): 209407
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The generic ingredient in ZUMANDIMINE is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 209407
Tradename: | ZUMANDIMINE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 209407
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZUMANDIMINE | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 209407 | ANDA | Aurobindo Pharma Limited | 59651-030 | 59651-030-28 | 1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK |
ZUMANDIMINE | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 209407 | ANDA | Aurobindo Pharma Limited | 59651-030 | 59651-030-85 | 3 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 3MG;0.03MG | ||||
Approval Date: | Mar 26, 2018 | TE: | AB | RLD: | No |
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