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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018582
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCALAMINE AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/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
05/06/1982 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
08/21/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
03/19/2013 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
12/24/2003 SUPPL-31 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18582scs031_procalAmine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18582scs031ltr.pdf
06/20/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
04/12/2000 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
05/04/1999 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
09/13/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
10/28/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
06/08/1993 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
09/28/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
12/11/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
04/11/1990 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
12/08/1987 SUPPL-17 Labeling

Label is not available on this site.
07/09/1987 SUPPL-16 Labeling

Label is not available on this site.
11/13/1986 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
05/21/1986 SUPPL-12 Labeling

Label is not available on this site.
06/14/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
04/11/1988 SUPPL-9 Labeling

Label is not available on this site.
03/07/1988 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/27/1985 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/10/1985 SUPPL-5 Labeling

Label is not available on this site.
09/10/1985 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.
07/01/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
08/26/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
07/19/1982 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
12/24/2003 SUPPL-31 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18582scs031_procalAmine_lbl.pdf
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