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FDA ANDA · ANDA207065

LEVONORGESTREL AND ETHINYL ESTRADIOL

Sponsor: NAARI PTE

APPLICATION
ANDA207065
TYPE
ANDA
ORIGINAL APPROVAL
2020-08-17
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 1 · standardAP
2020-08-17UNKNOWN · Original · standardAP
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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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