Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208083
Company: BAXTER HLTHCARE CORP
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;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 |
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. |
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 |