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FDA ANDA · ANDA202131

DROSPIRENONE AND ETHINYL ESTRADIOL

Sponsor: XIROMED

APPLICATION
ANDA202131
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-04
LATEST ACTION
2023-10-24
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

2023-10-24Labeling · Supplement 8 · standardAP
2023-10-24Labeling · Supplement 12 · standardAP
2018-12-07Labeling · Supplement 6 · standardAP
2018-12-07Labeling · Supplement 2 · standardAP
2018-12-07Labeling · Supplement 5 · standardAP
2015-05-04Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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