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FDA ANDA · ANDA063029

CLINDAMYCIN HYDROCHLORIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA063029
TYPE
ANDA
ORIGINAL APPROVAL
1989-09-20
LATEST ACTION
2012-04-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2012-04-10Labeling · Supplement 30AP
2010-08-20Labeling · Supplement 26AP
2005-11-14Labeling · Supplement 23AP
2005-08-05Labeling · Supplement 17AP
2005-08-05Manufacturing (CMC) · Supplement 16AP
2004-09-30Labeling · Supplement 15AP
2001-04-12Manufacturing (CMC) · Supplement 13AP
2000-08-09Labeling · Supplement 12AP
2000-07-07Manufacturing (CMC) · Supplement 11AP
2000-03-21Manufacturing (CMC) · Supplement 10AP
1999-06-24Manufacturing (CMC) · Supplement 8AP
1999-03-26Manufacturing (CMC) · Supplement 9AP
1998-09-14Labeling · Supplement 7AP
1997-09-09Manufacturing (CMC) · Supplement 6AP
1997-06-18Manufacturing (CMC) · Supplement 5AP
1997-04-17Manufacturing (CMC) · Supplement 4AP
1995-02-16Manufacturing (CMC) · Supplement 3AP
1994-09-06Manufacturing (CMC) · Supplement 2AP
1994-05-16Manufacturing (CMC) · Supplement 1AP
1989-09-20OriginalAP
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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