An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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/2023/020849s025lbl.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/2023/020849s025lbl.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

Top