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FDA ANDA · ANDA090081
DROSPIRENONE AND ETHINYL ESTRADIOL
Sponsor: DR REDDYS LABS SA
APPLICATION
ANDA090081
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-07
LATEST ACTION
2024-02-05
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
2024-02-05Labeling · Supplement 21 · standardAP
2023-04-27Labeling · Supplement 15 · standardAP
2023-04-27Labeling · Supplement 20 · standardAP
2015-05-29Labeling · Supplement 5 · 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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