← FDA DRUG APPROVALS
FDA ANDA · ANDA206866
CHATEAL EQ
levonorgestrel and ethinyl estradiol
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA206866
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-23
LATEST ACTION
2023-02-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AYUNAPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28
Approval history
2023-02-03Labeling · Supplement 6 · standardAP
2022-04-29Labeling · Supplement 5 · standardAP
2022-04-22Labeling · Supplement 4 · standardAP
2021-01-12Labeling · Supplement 3 · standardAP
2021-01-12Labeling · Supplement 2 · standardAP
2017-08-09Labeling · Supplement 1 · standardAP
2016-09-23UNKNOWN · 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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