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FDA ANDA · ANDA064050

CLINDAMYCIN PHOSPHATE

Sponsor: PADAGIS US

APPLICATION
ANDA064050
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-30
LATEST ACTION
2026-06-10
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2026-06-10Labeling · Supplement 28 · standardAP
2024-04-26Manufacturing (CMC) · Supplement 24 · unknownAP
2023-05-11Labeling · Supplement 22 · standardAP
2016-05-12Labeling · Supplement 12 · standardAP
2016-05-12Labeling · Supplement 10 · standardAP
2016-05-12Labeling · Supplement 9 · standardAP
2001-04-05Manufacturing (CMC) · Supplement 6AP
1999-11-08Manufacturing (CMC) · Supplement 3AP
1998-05-19Manufacturing (CMC) · Supplement 2AP
1995-11-30OriginalAP
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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