Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017957
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVAMINE 11.4% AMINO ACIDS 11.4% (11.4GM/100ML) INJECTABLE;INJECTION Discontinued None No No
NOVAMINE 15% AMINO ACIDS 15% (75GM/500ML) INJECTABLE;INJECTION Discontinued None No No
NOVAMINE 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
VEINAMINE 8% AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE 8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/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
01/03/1978 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
01/12/2005 SUPPL-39 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17957s039ltr.pdf
12/21/1999 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/11/1993 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/28/1993 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2003 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17957slr032ltr.pdf
04/05/1990 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/17/1987 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1987 SUPPL-26 Labeling

Label is not available on this site.

03/26/1987 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1986 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1986 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1986 SUPPL-22 Labeling

Label is not available on this site.

04/23/1985 SUPPL-21 Labeling

Label is not available on this site.

04/23/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1984 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1983 SUPPL-14 Labeling

Label is not available on this site.

06/07/1983 SUPPL-13 Labeling

Label is not available on this site.

08/09/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1982 SUPPL-10 Labeling

Label is not available on this site.

07/08/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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