← FDA DRUG APPROVALS
FDA ANDA · ANDA201821
CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)
clindamycin palmitate hydrochloride
Sponsor: RISING
APPLICATION
ANDA201821
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-28
LATEST ACTION
2022-08-22
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
CLINDAMYCIN PALMITATE HYDROCHLORIDEPrescription
CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML · FOR SOLUTION · ORAL
Approval history
2022-08-22Labeling · Supplement 5 · standardAP
2022-08-22Labeling · Supplement 3 · standardAP
2012-08-28Not Applicable · OriginalAP
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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