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FDA ANDA · ANDA202409
CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA202409
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-30
LATEST ACTION
2022-08-24
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
2022-08-24Labeling · Supplement 7 · standardAP
2022-08-24Labeling · Supplement 12 · standardAP
2022-08-24Labeling · Supplement 3 · standardAP
2022-08-24Labeling · Supplement 4 · standardAP
2022-08-24Labeling · Supplement 11 · standardAP
2022-08-24Labeling · Supplement 2 · standardAP
2013-04-30UNKNOWN · 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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