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FDA NDA · NDA050615

CLINDAMYCIN PHOSPHATE

Sponsor: PFIZER

APPLICATION
NDA050615
TYPE
NDA
ORIGINAL APPROVAL
1987-01-07
LATEST ACTION
2025-11-12
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

CLEOCIN T · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 1% BASE · GEL · TOPICAL

Approval history

2025-11-12Labeling · Supplement 21 · standard — Label ↗AP
2019-12-16Labeling · Supplement 19 · standard — Label ↗AP
2019-04-19Labeling · Supplement 18 · standard — Letter ↗AP
2017-11-16Labeling · Supplement 16 · standard — Label ↗AP
2016-01-15Labeling · Supplement 14 · standard — Label ↗AP
2015-01-12Manufacturing (CMC) · Supplement 13 · standardAP
2014-04-04Labeling · Supplement 12 · standard — Label ↗AP
2003-05-30Labeling · Supplement 5 · standard — Label ↗AP
2002-07-14Labeling · Supplement 3 — Label ↗AP
1998-01-27Manufacturing (CMC) · Supplement 4 · standardAP
1987-01-07Type 3 - New Dosage Form · Original · standardAP
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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