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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018676
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPATAMINE 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
08/03/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
11/17/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
03/19/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
04/29/2004 SUPPL-22 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18676scs022ltr.pdf
06/20/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
04/11/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
10/28/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
06/08/1993 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/28/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
12/11/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
04/11/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
01/13/1988 SUPPL-11 Labeling

Label is not available on this site.
07/09/1987 SUPPL-10 Labeling

Label is not available on this site.
11/13/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
10/03/1986 SUPPL-8 Labeling

Label is not available on this site.
07/16/1985 SUPPL-7 Labeling

Label is not available on this site.
04/10/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
10/03/1986 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/11/1988 SUPPL-4 Labeling

Label is not available on this site.
03/11/1988 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/13/1982 SUPPL-2 Labeling

Label is not available on this site.
10/15/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/29/2004 SUPPL-22 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf
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