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FDA ANDA · ANDA075796

AVIANE

levonorgestrel and ethinyl estradiol

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA075796
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-30
LATEST ACTION
2022-04-29
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

AVIANE-28Prescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG · TABLET · ORAL-28
AVIANE-21Discontinued
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG · TABLET · ORAL-21

Approval history

2022-04-29Labeling · Supplement 28 · standardAP
2022-02-17Labeling · Supplement 24 · standardAP
2017-08-09Labeling · Supplement 22 · standardAP
2010-03-30Labeling · Supplement 17AP
2002-06-19Manufacturing (CMC) · Supplement 5AP
2002-05-15Manufacturing (CMC) · Supplement 4AP
2002-05-03Manufacturing (CMC) · Supplement 3AP
2001-10-31Manufacturing (CMC) · Supplement 1AP
2001-04-30Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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