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FDA NDA · NDA050537

CLEOCIN

Sponsor: PFIZER

APPLICATION
NDA050537
TYPE
NDA
ORIGINAL APPROVAL
1980-07-09
LATEST ACTION
2025-11-12
ROUTE
TOPICAL
DOSAGE FORM
SWAB, SOLUTION
MARKETING STATUS
Discontinued

Products

CLEOCIN · ReferenceDiscontinued
CLINDAMYCIN PHOSPHATE EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SWAB · TOPICAL
CLEOCIN T · ReferenceDiscontinued
CLINDAMYCIN PHOSPHATE EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2025-11-12Labeling · Supplement 42 · standard — Label ↗AP
2019-12-16Labeling · Supplement 41 · standard — Label ↗AP
2019-04-19Labeling · Supplement 40 · standard — Letter ↗AP
2017-11-16Labeling · Supplement 39 · standard — Label ↗AP
2016-01-15Labeling · Supplement 37 · standard — Label ↗AP
2014-08-29Manufacturing (CMC) · Supplement 36 · standardAP
2014-04-04Labeling · Supplement 35 · standard — Letter ↗AP
2003-05-30Labeling · Supplement 26 · standard — Letter ↗AP
2002-07-14Labeling · Supplement 13 — Label ↗AP
1999-06-07Manufacturing (CMC) · Supplement 24 · standardAP
1994-09-05Manufacturing (CMC) · Supplement 23 · standardAP
1994-02-22Manufacturing (CMC) · Supplement 14 · standardAP
1992-12-21Manufacturing (CMC) · Supplement 16 · standardAP
1989-07-28Manufacturing (CMC) · Supplement 11 · standardAP
1989-03-15Labeling · Supplement 10AP
1986-07-18Labeling · Supplement 5AP
1986-01-23Manufacturing (CMC) · Supplement 7 · standardAP
1984-08-06Labeling · Supplement 6AP
1983-03-02Labeling · Supplement 4AP
1982-02-25Labeling · Supplement 21AP
1981-11-23Labeling · Supplement 19AP
1981-11-18Labeling · Supplement 18AP
1981-08-21Manufacturing (CMC) · Supplement 22 · standardAP
1981-05-11Labeling · Supplement 8AP
1981-04-20Labeling · Supplement 9AP
1980-09-30Manufacturing (CMC) · Supplement 3 · standardAP
1980-09-15Manufacturing (CMC) · Supplement 2 · standardAP
1980-08-14Labeling · Supplement 1AP
1980-07-09Type 3 - New Dosage Form · Original · standardAP
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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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