← FDA DRUG APPROVALS

FDA ANDA · ANDA087266

LINDANE

Sponsor: OLTA PHARMS

APPLICATION
ANDA087266
TYPE
ANDA
ORIGINAL APPROVAL
1981-12-17
LATEST ACTION
2004-04-05
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Discontinued

Products

LINDANEDiscontinued
LINDANE 1% · SHAMPOO · TOPICAL

Approval history

2004-04-05Labeling · Supplement 23AP
2001-10-09Manufacturing (CMC) · Supplement 21AP
2000-12-29Manufacturing (CMC) · Supplement 20AP
2000-12-29Manufacturing (CMC) · Supplement 19AP
1996-05-17Labeling · Supplement 17AP
1994-08-02Labeling · Supplement 16AP
1992-06-04Labeling · Supplement 13AP
1991-04-15Manufacturing (CMC) · Supplement 15AP
1990-09-28Manufacturing (CMC) · Supplement 14AP
1989-02-03Manufacturing (CMC) · Supplement 12AP
1989-01-26Manufacturing (CMC) · Supplement 11AP
1987-07-07Manufacturing (CMC) · Supplement 7AP
1986-01-17Manufacturing (CMC) · Supplement 5AP
1986-01-17Manufacturing (CMC) · Supplement 3AP
1986-01-17Manufacturing (CMC) · Supplement 4AP
1986-01-17Manufacturing (CMC) · Supplement 2AP
1981-12-17OriginalMedication GuideAP
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 →