Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019515
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS 5GM/100ML;53MG/100ML;100MG/100ML;100MG/100ML;180MG/100ML;280MG/100ML;16MG/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
05/08/1986 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
09/05/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/11/2001 SUPPL-16 Labeling

Label is not available on this site.

06/22/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2000 SUPPL-14 Labeling

Label is not available on this site.

08/06/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1992 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/13/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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