Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019683
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/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
11/07/1988 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
10/05/2005 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019683s027ltr.pdf
01/31/2003 SUPPL-21 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19683scs021ltr.pdf
11/08/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/2003 SUPPL-19 Labeling

Label is not available on this site.

10/29/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/30/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/05/2005 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf

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