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FDA ANDA · ANDA075803

LESSINA

levonorgestrel and ethinyl estradiol

Sponsor: BARR

APPLICATION
ANDA075803
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-20
LATEST ACTION
2022-04-29
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

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

Approval history

2022-04-29Labeling · Supplement 34 · standardAP
2017-08-09Labeling · Supplement 29 · standardAP
2002-11-27Manufacturing (CMC) · Supplement 4AP
2002-09-30Manufacturing (CMC) · Supplement 3AP
2002-09-30Manufacturing (CMC) · Supplement 1AP
2002-09-30Manufacturing (CMC) · Supplement 2AP
2002-03-20Original — 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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