Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 020360
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPATASOL 8% AMINO ACIDS 8% (8GM/100ML) INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/04/1996 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2003 SUPPL-8 Labeling

Label is not available on this site.

04/21/2000 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/28/2001 SUPPL-4 Labeling

Label is not available on this site.

06/11/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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