Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020849
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER AMINO ACIDS 20% (20GM/100ML) INJECTABLE;INJECTION 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
08/26/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20849lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20849ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020849_s000_Prosol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2018 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020849s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020849Orig1s024ltr.pdf
08/29/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/27/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/02/2003 SUPPL-8 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20849scs008ltr.pdf
04/24/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20849slr007ltr.pdf
08/14/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/14/2001 SUPPL-4 Labeling

Label is not available on this site.

03/24/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/25/1999 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
10/29/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020849s024lbl.pdf
08/26/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20849lbl.pdf

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