APPLICATION
ANDA207402
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-05
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
Approval history
2025-06-24Labeling · Supplement 8 · standardAP
2025-06-24Labeling · Supplement 6 · standardAP
2025-06-24Labeling · Supplement 2 · standardAP
2025-06-24Labeling · Supplement 7 · standardAP
2018-11-05UNKNOWN · Original · standardAP
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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