← FDA DRUG APPROVALS

FDA NDA · NDA050793

CLINDESSE

clindamycin phosphate

Sponsor: PADAGIS US

APPLICATION
NDA050793
TYPE
NDA
ORIGINAL APPROVAL
2004-11-30
LATEST ACTION
2025-01-30
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

CLINDESSE · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 2% BASE · CREAM · VAGINAL

Approval history

2025-01-30Labeling · Supplement 33 · standard — Label ↗AP
2023-11-03Labeling · Supplement 31 · standard — Letter ↗AP
2017-01-18Manufacturing (CMC) · Supplement 22 · standardAP
2016-03-01Manufacturing (CMC) · Supplement 21 · standardAP
2016-02-11Manufacturing (CMC) · Supplement 20 · standardAP
2014-09-22Manufacturing (CMC) · Supplement 19 · standardAP
2013-04-09Manufacturing (CMC) · Supplement 18 · standardAP
2013-01-16Manufacturing (CMC) · Supplement 17 · standardAP
2012-02-15Labeling · Supplement 15 · unknown — Label ↗AP
2010-12-15Labeling · Supplement 14 · unknown — Letter ↗AP
2004-11-30Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
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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