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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208083
Company: BAXTER HLTHCARE CORP

Products on NDA 208083

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	CLINDAMYCIN PHOSPHATE	EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208083

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208083Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208083Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208083s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208083Orig1s006,s007,s008ltr.pdf
09/01/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208083s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208083Orig1s006,s007,s008ltr.pdf
09/01/2022	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208083s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208083Orig1s006,s007,s008ltr.pdf
02/18/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208083s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208083Orig1s004ltr.pdf
08/01/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208083s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208083Orig1s003ltr.pdf
12/19/2017	SUPPL-1	Labeling-Container/Carton Labels		Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Label is not available on this site.

Labels for NDA 208083

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208083s006s007s008lbl.pdf
09/01/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208083s006s007s008lbl.pdf
09/01/2022	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208083s006s007s008lbl.pdf
02/18/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208083s004lbl.pdf
08/01/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208083s003lbl.pdf
04/20/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208083lbl.pdf

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