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FDA ANDA · ANDA087313

LINDANE

Sponsor: OLTA PHARMS

APPLICATION
ANDA087313
TYPE
ANDA
ORIGINAL APPROVAL
1981-12-17
LATEST ACTION
2001-09-04
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

LINDANEDiscontinued
LINDANE 1% · LOTION · TOPICAL

Approval history

2001-09-04Manufacturing (CMC) · Supplement 35AP
2001-08-21Manufacturing (CMC) · Supplement 34AP
1999-06-17Manufacturing (CMC) · Supplement 33AP
1998-11-16Manufacturing (CMC) · Supplement 32AP
1997-04-24Manufacturing (CMC) · Supplement 30AP
1996-05-17Labeling · Supplement 29AP
1994-08-02Labeling · Supplement 28AP
1993-03-04Labeling · Supplement 22AP
1993-01-12Manufacturing (CMC) · Supplement 27AP
1992-09-30Manufacturing (CMC) · Supplement 24AP
1991-04-15Manufacturing (CMC) · Supplement 23AP
1990-12-13Manufacturing (CMC) · Supplement 20AP
1990-09-28Manufacturing (CMC) · Supplement 21AP
1989-02-02Manufacturing (CMC) · Supplement 19AP
1988-12-15Manufacturing (CMC) · Supplement 17AP
1988-12-15Manufacturing (CMC) · Supplement 18AP
1988-03-30Labeling · Supplement 14AP
1987-07-08Manufacturing (CMC) · Supplement 11AP
1987-03-18Manufacturing (CMC) · Supplement 10AP
1986-04-01Manufacturing (CMC) · Supplement 4AP
1986-01-09Manufacturing (CMC) · Supplement 5AP
1986-01-09Manufacturing (CMC) · Supplement 6AP
1985-04-03Manufacturing (CMC) · Supplement 3AP
1983-01-25Manufacturing (CMC) · Supplement 2AP
1983-01-25Manufacturing (CMC) · Supplement 1AP
1981-12-17Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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