← FDA DRUG APPROVALS
FDA ANDA · ANDA062644
CLEOCIN PEDIATRIC
clindamycin palmitate hydrochloride
Sponsor: PFIZER
APPLICATION
ANDA062644
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-07
LATEST ACTION
2026-05-21
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
CLEOCINPrescription
CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML · FOR SOLUTION · ORAL
Approval history
2026-05-21Labeling · Supplement 34 · standardAP
2026-05-21Labeling · Supplement 32 · standardAP
2026-05-21Labeling · Supplement 35 · standardAP
2020-04-14Labeling · Supplement 31 · standardAP
2019-10-22Labeling · Supplement 28 · standardAP
2019-10-22Labeling · Supplement 29 · standardAP
2017-08-16Labeling · Supplement 27 · standardAP
2016-11-07Labeling · Supplement 24 · standardAP
2016-11-07Labeling · Supplement 19AP
2016-11-07Labeling · Supplement 25 · standardAP
2014-12-11Labeling · Supplement 9AP
2014-09-25Labeling · Supplement 21 · standardAP
2014-09-25Labeling · Supplement 22 · standardAP
1992-09-29Manufacturing (CMC) · Supplement 5AP
1986-04-07OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.