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Last Updated: November 2, 2024

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. 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:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:Feb 27, 2018TE:ABRLD:No

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