Details for New Drug Application (NDA): 209632
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NDA 209632 describes LO-ZUMANDIMINE, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the LO-ZUMANDIMINE profile page.
The generic ingredient in LO-ZUMANDIMINE 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 LO-ZUMANDIMINE 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 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 | ||||
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