Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018895
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TPN ELECTROLYTES IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/1984 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
06/12/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/14/2003 SUPPL-13 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18895scs013ltr.pdf
02/16/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1999 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/2000 SUPPL-9 Labeling

Label is not available on this site.

01/22/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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