← FDA DRUG APPROVALS

FDA ANDA · ANDA091072

RIVASTIGMINE TARTRATE

Sponsor: APOTEX INC

APPLICATION
ANDA091072
TYPE
ANDA
ORIGINAL APPROVAL
2013-05-16
LATEST ACTION
2019-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 4.5MG BASE · CAPSULE · ORAL
RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 1.5MG BASE · CAPSULE · ORAL
RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 6MG BASE · CAPSULE · ORAL
RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 3MG BASE · CAPSULE · ORAL

Approval history

2019-07-17Labeling · Supplement 7 · standardAP
2019-07-17Labeling · Supplement 8 · standardAP
2015-07-21Labeling · Supplement 6 · standardAP
2015-07-21Labeling · Supplement 2 · standardAP
2013-05-16OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →