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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020849
Company: BAXTER HLTHCARE

Products on NDA 020849

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020849

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
09/23/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018931s055,020849s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018931Orig1s055, 020849Orig1s025ltr.pdf
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.

Labels for NDA 020849

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018931s055,020849s025lbl.pdf
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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