APPLICATION
ANDA075866
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-23
LATEST ACTION
2023-02-06
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
PORTIA-21Discontinued
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-21
PORTIA-28Prescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28
Approval history
2023-02-06Labeling · Supplement 35 · standardAP
2022-04-29Labeling · Supplement 32 · standardAP
2022-03-09Labeling · Supplement 31 · standardAP
2017-08-09Labeling · Supplement 26 · standardAP
2014-02-21Labeling · Supplement 23 · standardAP
2003-01-03Manufacturing (CMC) · Supplement 5AP
2002-12-06Manufacturing (CMC) · Supplement 3AP
2002-12-06Manufacturing (CMC) · Supplement 1AP
2002-12-06Manufacturing (CMC) · Supplement 4AP
2002-12-06Manufacturing (CMC) · Supplement 2AP
2002-05-23OriginalAP
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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