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FDA ANDA · ANDA204848
DROSPIRENONE AND ETHINYL ESTRADIOL
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA204848
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-25
LATEST ACTION
2023-09-28
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
2023-09-28Labeling · Supplement 7 · standardAP
2023-09-28Labeling · Supplement 5 · standardAP
2023-09-28Labeling · Supplement 1 · standardAP
2016-03-25UNKNOWN · 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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