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FDA ANDA · ANDA203163

ASHLYNA

levonorgestrel and ethinyl estradiol and ethinyl estradiol

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA203163
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-23
LATEST ACTION
2023-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ASHLYNAPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL

Approval history

2023-07-31Labeling · Supplement 5 · standardAP
2023-07-31Labeling · Supplement 3 · standardAP
2021-01-13Labeling · Supplement 1 · standardAP
2015-02-23UNKNOWN · OriginalAP
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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