← FDA DRUG APPROVALS

FDA ANDA · ANDA078173

RIZATRIPTAN BENZOATE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA078173
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-31
LATEST ACTION
2021-04-07
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

RIZATRIPTAN BENZOATEDiscontinued
RIZATRIPTAN BENZOATE EQ 10MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
RIZATRIPTAN BENZOATEDiscontinued
RIZATRIPTAN BENZOATE EQ 5MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2021-04-07Labeling · Supplement 7 · standardAP
2015-11-09Labeling · Supplement 5 · standardAP
2015-02-10Manufacturing (CMC) · Supplement 2 · unknownAP
2012-12-31OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →