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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 209407


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NDA 209407 describes ZUMANDIMINE, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ZUMANDIMINE profile page.

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:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:Mar 26, 2018TE:ABRLD:No

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