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FDA NDA · NDA050639

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: PFIZER

APPLICATION
NDA050639
TYPE
NDA
ORIGINAL APPROVAL
1989-08-30
LATEST ACTION
2026-03-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2026-03-26Labeling · Supplement 45 · standard — Label ↗AP
2026-02-12Labeling · Supplement 44 · standard — Letter ↗AP
2022-05-20Labeling · Supplement 42 · standard — Letter ↗AP
2021-12-04Labeling · Supplement 43 · standard — Label ↗AP
2020-03-04Labeling · Supplement 41 · standard — Letter ↗AP
2019-06-19Labeling · Supplement 40 · standard — Label ↗AP
2018-04-16Labeling · Supplement 38 · standard — Label ↗AP
2017-05-02Labeling · Supplement 37 · standard — Label ↗AP
2017-05-02Labeling · Supplement 35 · standard — Label ↗AP
2016-08-05Labeling · Supplement 33 · standard — Letter ↗AP
2016-08-05Labeling · Supplement 34 · standard — Letter ↗AP
2016-05-20Manufacturing (CMC) · Supplement 32 · standardAP
2016-03-24Labeling · Supplement 31 · standard — Label ↗AP
2014-09-18Manufacturing (CMC) · Supplement 30 · standardAP
2014-06-25Labeling · Supplement 29 · standard — Label ↗AP
2014-06-25Labeling · Supplement 27 · standard — Letter ↗AP
2014-06-25Labeling · Supplement 28 · standard — Label ↗AP
2013-10-09Manufacturing (CMC) · Supplement 26 · standardAP
2013-06-26Manufacturing (CMC) · Supplement 25 · standardAP
2011-06-07Labeling · Supplement 22 · unknown — Letter ↗AP
2008-04-14Labeling · Supplement 16 · standard — Letter ↗AP
2008-02-21Labeling · Supplement 15 · standard — Label ↗AP
2004-09-29Labeling · Supplement 13 · standard — Label ↗AP
2004-01-28Labeling · Supplement 14 · standard — Letter ↗AP
1998-03-09Manufacturing (CMC) · Supplement 10 · standardAP
1997-12-12Labeling · Supplement 12 · standardAP
1997-07-17Labeling · Supplement 11 · standardAP
1997-03-17Labeling · Supplement 5AP
1995-12-20Labeling · Supplement 7 · standardAP
1995-02-21Labeling · Supplement 9 · standardAP
1993-04-05Manufacturing (CMC) · Supplement 8 · standardAP
1992-05-21Manufacturing (CMC) · Supplement 4 · standardAP
1991-06-11Labeling · Supplement 2AP
1991-04-18Manufacturing (CMC) · Supplement 1 · standardAP
1991-04-10Manufacturing (CMC) · Supplement 3 · standardAP
1989-08-30Type 3 - New Dosage Form · Original · standardAP
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