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FDA ANDA · ANDA213034

DROSPIRENONE AND ETHINYL ESTRADIOL

Sponsor: HETERO LABS

APPLICATION
ANDA213034
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-24
LATEST ACTION
2024-12-26
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DROSPIRENONE AND ETHINYL ESTRADIOLPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28

Approval history

2024-12-26Labeling · Supplement 4 · standardAP
2024-12-26Labeling · Supplement 2 · standardAP
2020-01-24UNKNOWN · 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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