Details for New Drug Application (NDA): 209632
✉ Email this page to a colleague
The generic ingredient in LO-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 209632
Tradename: | LO-ZUMANDIMINE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 209632
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LO-ZUMANDIMINE | drospirenone; ethinyl estradiol | TABLET;ORAL | 209632 | ANDA | Afaxys Pharma, LLC | 50102-240 | 50102-240-23 | 3 POUCH in 1 CARTON (50102-240-23) / 1 BLISTER PACK in 1 POUCH (50102-240-21) / 1 KIT in 1 BLISTER PACK |
LO-ZUMANDIMINE | drospirenone; ethinyl estradiol | TABLET;ORAL | 209632 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1783 | 53002-1783-1 | 1 KIT in 1 BLISTER PACK (53002-1783-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG;0.02MG | ||||
Approval Date: | Feb 27, 2018 | TE: | AB | RLD: | No |
Complete Access Available with Subscription