← FDA DRUG APPROVALS

FDA NDA · NDA050767

CLEOCIN

clindamycin phosphate

Sponsor: PFIZER

APPLICATION
NDA050767
TYPE
NDA
ORIGINAL APPROVAL
1999-08-13
LATEST ACTION
2022-07-26
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription

Products

CLEOCIN · ReferencePrescription
CLINDAMYCIN PHOSPHATE 100MG · SUPPOSITORY · VAGINAL

Approval history

2022-07-26Labeling · Supplement 19 · standard — Letter ↗AP
2022-05-17Labeling · Supplement 18 · standard — Letter ↗AP
2020-03-23Labeling · Supplement 17 · standard — Label ↗AP
2019-09-16Labeling · Supplement 16 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 15 · standard — Label ↗AP
2017-09-08Labeling · Supplement 14 · standard — Label ↗AP
2015-07-13Labeling · Supplement 12 · standard — Label ↗AP
2014-05-09Labeling · Supplement 11 · standard — Letter ↗AP
2013-06-19Labeling · Supplement 10 · standard — Label ↗AP
2000-05-15Manufacturing (CMC) · Supplement 1 · standardAP
1999-08-13Type 3 - New Dosage Form · 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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