← FDA DRUG APPROVALS

FDA NDA · NDA050162

CLEOCIN HYDROCHLORIDE

clindamycin hydrochloride

Sponsor: PFIZER

APPLICATION
NDA050162
TYPE
NDA
ORIGINAL APPROVAL
1970-02-22
LATEST ACTION
2026-03-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CLEOCIN HYDROCHLORIDE · ReferencePrescription
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLEOCIN HYDROCHLORIDE · ReferencePrescription
CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
CLEOCIN HYDROCHLORIDE · ReferencePrescription
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2026-03-26Labeling · Supplement 107 · standard — Label ↗AP
2026-02-12Labeling · Supplement 106 · standard — Letter ↗AP
2024-07-29Labeling · Supplement 105 · standard — Letter ↗AP
2022-05-20Labeling · Supplement 104 · standard — Letter ↗AP
2020-03-09Labeling · Supplement 102 · standard — Letter ↗AP
2019-06-13Labeling · Supplement 101 · standard — Label ↗AP
2018-03-15Labeling · Supplement 100 · standard — Label ↗AP
2017-05-02Labeling · Supplement 99 · standard — Label ↗AP
2017-05-02Labeling · Supplement 98 · standard — Label ↗AP
2016-08-02Labeling · Supplement 97 · standardAP
2016-03-23Labeling · Supplement 96 · standard — Label ↗AP
2016-03-23Labeling · Supplement 95 · standard — Letter ↗AP
2016-01-21Manufacturing (CMC) · Supplement 94AP
2014-06-26Labeling · Supplement 92 · standard — Letter ↗AP
2014-06-26Labeling · Supplement 93 · standard — Label ↗AP
2011-06-07Labeling · Supplement 90 · unknown — Letter ↗AP
2009-11-20Labeling · Supplement 85 · standard — Letter ↗AP
2004-09-29Labeling · Supplement 82 · standard — Label ↗AP
2004-01-28Labeling · Supplement 84 · standard — Letter ↗AP
1999-11-15Manufacturing (CMC) · Supplement 83AP
1998-02-24Manufacturing (CMC) · Supplement 81AP
1997-12-12Labeling · Supplement 80 · standardAP
1997-07-17Labeling · Supplement 79 · standardAP
1997-03-17Labeling · Supplement 18AP
1997-03-17Labeling · Supplement 22AP
1997-03-17Labeling · Supplement 9AP
1995-02-21Labeling · Supplement 20AP
1993-03-05Manufacturing (CMC) · Supplement 21AP
1988-04-14Efficacy · Supplement 11AP
1986-10-20Labeling · Supplement 10AP
1985-09-10Labeling · Supplement 5AP
1985-06-21Labeling · Supplement 7AP
1983-04-29Manufacturing (CMC) · Supplement 4AP
1982-04-27Manufacturing (CMC) · Supplement 77AP
1981-11-03Efficacy · Supplement 76AP
1981-05-20Manufacturing (CMC) · Supplement 75AP
1980-05-27Manufacturing (CMC) · Supplement 74AP
1980-04-30Labeling · Supplement 73AP
1979-11-06Labeling · Supplement 72AP
1979-07-20Manufacturing (CMC) · Supplement 71AP
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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