APPLICATION
ANDA075809
TYPE
ANDA
ORIGINAL APPROVAL
2001-07-16
LATEST ACTION
2022-04-29
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
ENPRESSE-28Prescription
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-28
ENPRESSE-21Discontinued
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-21
Approval history
2022-04-29Labeling · Supplement 31 · standardAP
2022-01-28Labeling · Supplement 27 · standardAP
2022-01-28Labeling · Supplement 25 · standardAP
2017-08-09Labeling · Supplement 24 · standardAP
2002-06-19Manufacturing (CMC) · Supplement 4AP
2002-05-21Manufacturing (CMC) · Supplement 3AP
2002-03-12Manufacturing (CMC) · Supplement 2AP
2001-07-16OriginalAP
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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