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FDA NDA · NDA208083

CLINDAMYCIN PHOSPHATE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA208083
TYPE
NDA
ORIGINAL APPROVAL
2017-04-20
LATEST ACTION
2022-09-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 900MG BASE/50ML (EQ 18MG BASE/ML) · SOLUTION · INTRAVENOUS
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 300MG BASE/50ML (EQ 6MG BASE/ML) · SOLUTION · INTRAVENOUS
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
CLINDAMYCIN PHOSPHATE EQ 600MG BASE/50ML (EQ 12MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-09-01Labeling · Supplement 7 · standard — Letter ↗AP
2022-09-01Labeling · Supplement 8 · standard — Letter ↗AP
2022-09-01Labeling · Supplement 6 · standard — Letter ↗AP
2021-02-18Labeling · Supplement 4 · standard — Label ↗AP
2019-08-01Labeling · Supplement 3 · standard — Label ↗AP
2017-12-19Labeling · Supplement 1 · standardAP
2017-04-20Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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