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FDA ANDA · ANDA064136

CLINDETS

Sponsor: PERRIGO CO

APPLICATION
ANDA064136
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-30
LATEST ACTION
2003-12-09
ROUTE
TOPICAL
DOSAGE FORM
SWAB
MARKETING STATUS
Discontinued

Products

CLINDETSDiscontinued
CLINDAMYCIN PHOSPHATE EQ 1% BASE · SWAB · TOPICAL

Approval history

2003-12-09Labeling · Supplement 8AP
2002-11-01Labeling · Supplement 5AP
2002-10-17Manufacturing (CMC) · Supplement 4AP
2001-06-29Manufacturing (CMC) · Supplement 3AP
1999-10-22Manufacturing (CMC) · Supplement 2AP
1997-07-29Manufacturing (CMC) · Supplement 1AP
1996-09-30OriginalAP
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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