Prosol 20% Sulfite Free In Plastic Container

NDA 20849, held by Baxter Hlthcare. Amino Acids.

As of Nov 13, 2026, NDA 20849 (Prosol 20% Sulfite Free In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Aug 26, 1998, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1998
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Aug 26, 1998	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prosol 20% Sulfite Free In Plastic Container20% (20GM/100ML) · injectable;injection	Amino Acids	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Sep 23, 2020	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 29, 2018	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 29, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 27, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
May 2, 2003	Supplement 8Manufacturing · Standard review	Approved	Letter
Apr 24, 2003	Supplement 7Labeling · Standard review	Approved	Letter
Nov 14, 2001	Supplement 4Labeling · Standard review	Approved	None posted
Aug 14, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 24, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 24, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
May 25, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 26, 1998	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 20849
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters