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FDA ANDA · ANDA088191

LINDANE

Sponsor: WOCKHARDT BIO AG

APPLICATION
ANDA088191
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-18
LATEST ACTION
2007-08-22
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Discontinued

Products

LINDANEDiscontinued
LINDANE 1% · SHAMPOO · TOPICAL

Approval history

2007-08-22Labeling · Supplement 25AP
1997-03-27Labeling · Supplement 22AP
1995-06-28Labeling · Supplement 21AP
1994-08-02Labeling · Supplement 20AP
1989-10-24Labeling · Supplement 18AP
1989-02-22Manufacturing (CMC) · Supplement 17AP
1988-08-10Manufacturing (CMC) · Supplement 16AP
1987-06-24Manufacturing (CMC) · Supplement 12AP
1987-06-24Manufacturing (CMC) · Supplement 13AP
1987-05-18Manufacturing (CMC) · Supplement 10AP
1987-05-18Manufacturing (CMC) · Supplement 9AP
1986-09-23Manufacturing (CMC) · Supplement 6AP
1986-07-24Manufacturing (CMC) · Supplement 7AP
1984-11-23Manufacturing (CMC) · Supplement 2AP
1984-11-23Manufacturing (CMC) · Supplement 3AP
1984-11-23Manufacturing (CMC) · Supplement 1AP
1984-09-18Original — 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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