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FDA ANDA · ANDA073594

LEVORA

levonorgestrel and ethinyl estradiol

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA073594
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-13
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVORA 0.15/30-28Prescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 31 · standardAP
2022-03-07Labeling · Supplement 28 · standardAP
2022-03-07Labeling · Supplement 30 · standardAP
2017-08-09Labeling · Supplement 26 · standardAP
2017-07-24Labeling · Supplement 25 · standardAP
2014-02-07Labeling · Supplement 24 · standardAP
2001-08-16Manufacturing (CMC) · Supplement 6AP
1996-10-31Manufacturing (CMC) · Supplement 3AP
1996-07-10Labeling · Supplement 2AP
1996-06-10Manufacturing (CMC) · Supplement 1AP
1993-12-13OriginalAP
VIEW ON DRUGS@FDA ↗

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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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