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FDA ANDA · ANDA091247
AZURETTE
desogestrel/ethinyl estradiol and ethinyl estradiol
Sponsor: NOVAST LABS
APPLICATION
ANDA091247
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-01
LATEST ACTION
2024-07-08
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PIMTREAPrescription
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG · TABLET · ORAL-28
Approval history
2024-07-08Labeling · Supplement 10 · standardAP
2022-04-29Labeling · Supplement 9 · standardAP
2020-12-31Labeling · Supplement 8 · standardAP
2019-10-28Labeling · Supplement 3 · standardAP
2017-08-09Labeling · Supplement 2 · standardAP
2013-08-01OriginalAP
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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