← FDA DRUG APPROVALS

FDA NDA · NDA050600

CLINDAMYCIN PHOSPHATE

Sponsor: PFIZER

APPLICATION
NDA050600
TYPE
NDA
ORIGINAL APPROVAL
1989-05-31
LATEST ACTION
2025-11-12
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription

Products

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

Approval history

2025-11-12Labeling · Supplement 20 · standard — Label ↗AP
2019-12-16Labeling · Supplement 18 · standard — Label ↗AP
2019-04-19Labeling · Supplement 17 · standard — Letter ↗AP
2017-11-16Labeling · Supplement 16 · standard — Label ↗AP
2016-01-15Labeling · Supplement 14 · standard — Label ↗AP
2014-04-04Labeling · Supplement 13 · standard — Label ↗AP
2003-05-30Labeling · Supplement 7 · standard — Letter ↗AP
2002-07-14Labeling · Supplement 2 — Label ↗AP
1994-09-05Manufacturing (CMC) · Supplement 6 · standardAP
1993-10-20Manufacturing (CMC) · Supplement 5 · standardAP
1993-04-07Manufacturing (CMC) · Supplement 1 · standardAP
1991-09-23Manufacturing (CMC) · Supplement 3 · standardAP
1989-05-31Type 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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