Hepatasol 8%

ANDA 20360, held by Baxter Hlthcare. Amino Acids.

As of Nov 15, 2026, ANDA 20360 (Hepatasol 8%), held by Baxter Hlthcare, was first approved by FDA on Apr 4, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1996
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 4, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hepatasol 8%8% (8GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Sep 8, 2003	Supplement 8Labeling	Approved	None posted
Feb 28, 2001	Supplement 4Labeling	Approved	None posted
Apr 21, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 11, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 16, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 13, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 4, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: ANDA 20360
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