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FDA ANDA · ANDA206867
AMAZON BASIC CARE LEVONORGESTREL
levonorgestrel
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA206867
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-08
LATEST ACTION
2022-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
ATHENTIA NEXTOver-the-counter
LEVONORGESTREL 1.5MG · TABLET · ORAL
Approval history
2022-01-26Labeling · Supplement 4 · standardAP
2020-11-30Labeling · Supplement 3 · standardAP
2016-08-23Labeling · Supplement 1 · standardAP
2015-12-08UNKNOWN · Original · standardAP
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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