← FDA DRUG APPROVALS

FDA NDA · NDA050680

CLINDAMYCIN PHOSPHATE

Sponsor: PFIZER

APPLICATION
NDA050680
TYPE
NDA
ORIGINAL APPROVAL
1992-08-11
LATEST ACTION
2022-05-17
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription, Discontinued

Products

CLEOCIN · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 2% BASE · CREAM · VAGINAL
CLEOCINDiscontinued
CLINDAMYCIN PHOSPHATE EQ 2% BASE · CREAM · VAGINAL

Approval history

2022-05-17Labeling · Supplement 19 · standard — Letter ↗AP
2020-03-23Labeling · Supplement 18 · standard — Label ↗AP
2019-05-21Labeling · Supplement 17 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 16 · standard — Label ↗AP
2017-09-08Labeling · Supplement 13 · standard — Label ↗AP
2015-07-13Labeling · Supplement 11 · standard — Letter ↗AP
2014-05-09Labeling · Supplement 10 · standard — Label ↗AP
2003-08-20Labeling · Supplement 4 · standard — Letter ↗AP
1998-03-02Efficacy · Supplement 2 · standard — Letter ↗AP
1996-08-05Manufacturing (CMC) · Supplement 3 · standardAP
1995-10-05Efficacy · Supplement 1 · unknownAP
1992-08-11Type 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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