← FDA DRUG APPROVALS

FDA ANDA · ANDA078027

ALMOTRIPTAN MALATE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA078027
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-07
LATEST ACTION
2020-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALMOTRIPTAN MALATEPrescription
ALMOTRIPTAN MALATE EQ 6.25MG BASE · TABLET · ORAL
ALMOTRIPTAN MALATEPrescription
ALMOTRIPTAN MALATE EQ 12.5MG BASE · TABLET · ORAL

Approval history

2020-09-29Labeling · Supplement 2 · standardAP
2015-07-07Original — Letter ↗AP
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 →