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FDA ANDA · ANDA091692

DOLISHALE

levonorgestrel and ethinyl estradiol

Sponsor: NOVAST LABS

APPLICATION
ANDA091692
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-22
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DOLISHALEPrescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.09MG · TABLET · ORAL

Approval history

2022-04-29Labeling · Supplement 3 · standardAP
2020-10-22OriginalAP
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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