Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016822
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FREAMINE 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
FREAMINE HBC 6.9% AMINO ACIDS 6.9% (6.9GM/100ML) INJECTABLE;INJECTION Prescription None No No
FREAMINE II 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
FREAMINE III 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription None No No
FREAMINE III 3% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE;INJECTION Prescription None No No
FREAMINE III 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Prescription None No No
FREAMINE III 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/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
09/24/1971 ORIG-1 Approval Type 4 - New Combination PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2013 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

01/09/2013 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

03/15/2013 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

03/19/2013 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

03/12/2014 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

05/27/2004 SUPPL-65 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16822scs065ltr.pdf
06/20/2000 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1999 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1996 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1995 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1994 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

12/11/1991 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/11/1990 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1988 SUPPL-52 Labeling

Label is not available on this site.

12/28/1987 SUPPL-51 Labeling

Label is not available on this site.

07/09/1987 SUPPL-50 Labeling

Label is not available on this site.

07/09/1987 SUPPL-49 Labeling

Label is not available on this site.

10/08/1986 SUPPL-48 Labeling

Label is not available on this site.

10/21/1985 SUPPL-47 Labeling

Label is not available on this site.

10/21/1985 SUPPL-46 Labeling

Label is not available on this site.

06/14/1985 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1988 SUPPL-44 Labeling

Label is not available on this site.

07/01/1988 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1984 SUPPL-42 Labeling

Label is not available on this site.

04/11/1988 SUPPL-41 Labeling

Label is not available on this site.

04/11/1988 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/1985 SUPPL-39 Labeling

Label is not available on this site.

10/15/1985 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1985 SUPPL-37 Labeling

Label is not available on this site.

07/23/1985 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1982 SUPPL-35 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/26/1982 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1983 SUPPL-33 Labeling

Label is not available on this site.

05/17/1983 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1982 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1983 SUPPL-30 Labeling

Label is not available on this site.

06/17/1982 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1981 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1981 SUPPL-26 Labeling

Label is not available on this site.

06/20/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1980 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1980 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/07/1980 SUPPL-21 Labeling

Label is not available on this site.

08/07/1980 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1980 SUPPL-16 Labeling

Label is not available on this site.

04/17/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1978 SUPPL-13 Labeling

Label is not available on this site.

10/02/1978 SUPPL-12 Labeling

Label is not available on this site.

10/02/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1977 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1977 SUPPL-7 Efficacy

Label is not available on this site.

05/06/1977 SUPPL-6 Labeling

Label is not available on this site.

01/23/1975 SUPPL-5 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
05/27/2004 SUPPL-65 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.pdf

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