APPLICATION
ANDA090541
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-02
LATEST ACTION
2022-09-02
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription
Products
TRI-LO-LINYAHNone (Tentative Approval)
NORGESTIMATE 0.25MG, ETHINYL ESTRADIOL 0.025MG · TABLET · ORAL
TRI-LO-LINYAHPrescription
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
TRI-LO-LINYAHNone (Tentative Approval)
NORGESTIMATE 0.215MG, ETHINYL ESTRADIOL 0.025MG · TABLET · ORAL
Approval history
2022-09-02OriginalAP
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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