← FDA DRUG APPROVALS

FDA ANDA · ANDA202764

GABAPENTIN

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA202764
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-16
LATEST ACTION
2021-06-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL

Approval history

2021-06-02Labeling · Supplement 21 · standardAP
2021-06-02Labeling · Supplement 8 · standardAP
2021-06-02Labeling · Supplement 6 · standardAP
2021-06-02Labeling · Supplement 24 · standardAP
2021-06-02Labeling · Supplement 7 · standardAP
2021-06-02Labeling · Supplement 25 · standardAP
2014-09-25Labeling · Supplement 4 · standardAP
2012-10-16UNKNOWN · OriginalAP
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 →