← FDA DRUG APPROVALS

FDA NDA · NDA050441

CLEOCIN PHOSPHATE

clindamycin phosphate

Sponsor: PFIZER

APPLICATION
NDA050441
TYPE
NDA
ORIGINAL APPROVAL
1972-10-02
LATEST ACTION
2026-03-26
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CLEOCIN PHOSPHATE · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML · INJECTABLE · INJECTION

Approval history

2026-03-26Labeling · Supplement 91 · standard — Label ↗AP
2026-02-12Labeling · Supplement 90 · standard — Letter ↗AP
2022-05-20Labeling · Supplement 85 · standard — Letter ↗AP
2021-12-04Labeling · Supplement 86 · standard — Label ↗AP
2020-03-04Labeling · Supplement 83 · standard — Letter ↗AP
2019-06-19Labeling · Supplement 81 · standard — Label ↗AP
2018-04-16Labeling · Supplement 79 · standard — Label ↗AP
2017-05-02Labeling · Supplement 78 · standard — Label ↗AP
2017-05-02Labeling · Supplement 76 · standard — Label ↗AP
2016-08-05Labeling · Supplement 72 · standard — Letter ↗AP
2016-08-05Labeling · Supplement 73 · standard — Letter ↗AP
2016-03-24Labeling · Supplement 71 · standard — Letter ↗AP
2014-10-20Manufacturing (CMC) · Supplement 70AP
2014-06-10Labeling · Supplement 66 · standard — Label ↗AP
2014-06-10Labeling · Supplement 67 · standard — Letter ↗AP
2014-06-10Labeling · Supplement 68 · standard — Label ↗AP
2012-12-18Manufacturing (CMC) · Supplement 64AP
2011-06-07Labeling · Supplement 61 · unknown — Letter ↗AP
2010-10-15Labeling · Supplement 59 · unknown — Letter ↗AP
2008-04-14Labeling · Supplement 55 · standard — Label ↗AP
2008-02-21Labeling · Supplement 53 · standard — Letter ↗AP
2004-09-29Labeling · Supplement 45 · standard — Label ↗AP
2004-01-28Labeling · Supplement 48 · standard — Letter ↗AP
2001-11-21Labeling · Supplement 47 · standard — Label ↗AP
2000-04-03Manufacturing (CMC) · Supplement 46AP
1997-12-12Labeling · Supplement 44 · standardAP
1997-07-17Labeling · Supplement 43 · standardAP
1997-03-17Labeling · Supplement 38AP
1997-03-17Labeling · Supplement 25AP
1997-03-17Labeling · Supplement 23AP
1996-03-05Labeling · Supplement 40AP
1995-12-20Labeling · Supplement 41 · standardAP
1995-02-21Labeling · Supplement 42AP
1993-03-23Manufacturing (CMC) · Supplement 37AP
1991-06-11Labeling · Supplement 35AP
1972-10-02UNKNOWN · Original · unknownAP
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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