Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208083
Company: BAXTER HLTHCARE CORP
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;IV (INFUSION) Prescription None Yes Yes
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE CLINDAMYCIN PHOSPHATE EQ 600MG BASE/50ML (EQ 12MG BASE/ML) SOLUTION;IV (INFUSION) Prescription None Yes Yes
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE CLINDAMYCIN PHOSPHATE EQ 900MG BASE/50ML (EQ 18MG BASE/ML) SOLUTION;IV (INFUSION) Prescription None Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/20/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208083lbl.pdf

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