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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019018
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROPHAMINE AMINO ACIDS 6% (6GM/100ML) INJECTABLE;INJECTION Prescription None Yes Yes
TROPHAMINE 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/1984 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
10/26/2020 SUPPL-36 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019018Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019018Orig1s036ltr.pdf
01/17/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
11/08/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
03/19/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
03/24/2004 SUPPL-18 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19018scs018ltr.pdf
06/20/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
04/11/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
10/28/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
09/28/1992 SUPPL-13 Manufacturing (CMC)

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

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

Label is not available on this site.
04/23/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
12/19/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
09/07/1988 SUPPL-6 Labeling

Label is not available on this site.
09/07/1988 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.
01/13/1988 SUPPL-4 Labeling

Label is not available on this site.
07/09/1987 SUPPL-3 Labeling

Label is not available on this site.
10/09/1986 SUPPL-2 Labeling

Label is not available on this site.
02/21/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/26/2020 SUPPL-36 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019018Orig1s036lbl.pdf
03/24/2004 SUPPL-18 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl.pdf
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