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FDA ANDA · ANDA077526

RIZATRIPTAN BENZOATE

Sponsor: CHARTWELL RX

APPLICATION
ANDA077526
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-26
LATEST ACTION
2020-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RIZATRIPTAN BENZOATEPrescription
RIZATRIPTAN BENZOATE EQ 5MG BASE · TABLET · ORAL
RIZATRIPTAN BENZOATEPrescription
RIZATRIPTAN BENZOATE EQ 10MG BASE · TABLET · ORAL

Approval history

2020-01-29Labeling · Supplement 2 · standardAP
2015-11-27Manufacturing (CMC) · Supplement 1 · unknownAP
2013-03-26OriginalAP
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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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