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FDA ANDA · ANDA209632

DROSPIRENONE AND ETHINYL ESTRADIOL

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA209632
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-27
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LO-ZUMANDIMINEPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL

Approval history

2023-08-16Labeling · Supplement 3 · standardAP
2023-08-16Labeling · Supplement 2 · standardAP
2018-02-27UNKNOWN · Original · standardAP
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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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