← FDA DRUG APPROVALS

FDA ANDA · ANDA071919

NALIDIXIC ACID

Sponsor: WATSON LABS

APPLICATION
ANDA071919
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-28
LATEST ACTION
1996-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NALIDIXIC ACIDDiscontinued
NALIDIXIC ACID 1GM · TABLET · ORAL

Approval history

1996-05-20Labeling · Supplement 6AP
1991-07-31Manufacturing (CMC) · Supplement 3AP
1991-07-31Manufacturing (CMC) · Supplement 2AP
1991-01-28Manufacturing (CMC) · Supplement 5AP
1990-06-29Manufacturing (CMC) · Supplement 1AP
1988-06-28OriginalAP
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 →