APPLICATION
ANDA090999
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-24
LATEST ACTION
2020-12-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
APREPITANTPrescription
APREPITANT 125MG · CAPSULE · ORAL
APREPITANTPrescription
APREPITANT 40MG · CAPSULE · ORAL
APREPITANTPrescription
APREPITANT 80MG · CAPSULE · ORAL
Approval history
2020-12-23Labeling · Supplement 14 · standardAP
2020-12-23Labeling · Supplement 12 · standardAP
2016-09-28Labeling · Supplement 9 · standardAP
2016-09-28Manufacturing (CMC) · Supplement 10 · unknownAP
2015-07-20Labeling · Supplement 8 · standardAP
2015-07-20Labeling · Supplement 6 · 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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