Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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 Prescription 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English