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FDA ANDA · ANDA063304

CLINDAMYCIN PHOSPHATE

Sponsor: XTTRIUM LABS INC

APPLICATION
ANDA063304
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-15
LATEST ACTION
2001-05-15
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CLINDAMYCIN PHOSPHATEDiscontinued
CLINDAMYCIN PHOSPHATE EQ 1% BASE · SOLUTION · TOPICAL

Approval history

2001-05-15Manufacturing (CMC) · Supplement 3AP
2001-05-15Manufacturing (CMC) · Supplement 4AP
2000-04-03Manufacturing (CMC) · Supplement 1AP
1997-07-15OriginalAP
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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