← FDA DRUG APPROVALS

FDA ANDA · ANDA200043

ARMODAFINIL

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA200043
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-01
LATEST ACTION
2019-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ARMODAFINILPrescription
ARMODAFINIL 100MG · TABLET · ORAL
ARMODAFINILPrescription
ARMODAFINIL 150MG · TABLET · ORAL
ARMODAFINILPrescription
ARMODAFINIL 200MG · TABLET · ORAL
ARMODAFINILPrescription
ARMODAFINIL 250MG · TABLET · ORAL
ARMODAFINILPrescription
ARMODAFINIL 50MG · TABLET · ORAL

Approval history

2019-12-13Labeling · Supplement 6 · standardAP
2019-05-09Not Applicable · OriginalAP
2016-01-20Labeling · Supplement 4 · standardAP
2016-01-20Labeling · Supplement 1 · standardAP
2012-06-01Not Applicable · Original — Letter ↗AP
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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