APPLICATION
ANDA205186
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-29
LATEST ACTION
2020-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ELETRIPTAN HYDROBROMIDEPrescription
ELETRIPTAN HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL
ELETRIPTAN HYDROBROMIDEPrescription
ELETRIPTAN HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL
Approval history
2020-11-09Labeling · Supplement 7 · standardAP
2018-07-20Manufacturing (CMC) · Supplement 2AP
2017-08-29UNKNOWN · 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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