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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204508
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINOLIPID 20% OLIVE OIL; SOYBEAN OIL 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION;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
10/03/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204508Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2021 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204508s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020678Orig1s042, 020734Orig1s037, 204508Orig1s015ltr.pdf
01/09/2017 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/20/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204508Orig1s005ltr.pdf
02/08/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/26/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/20/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/06/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/13/2021 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204508s015lbl.pdf
07/20/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf
10/03/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf
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