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FDA ANDA · ANDA209407
ZUMANDIMINE
drospirenone and ethinyl estradiol
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA209407
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-26
LATEST ACTION
2023-09-19
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZUMANDIMINEPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2023-09-19Labeling · Supplement 2 · standardAP
2023-09-19Labeling · Supplement 3 · standardAP
2018-03-26UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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