Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018608
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLEGISOL IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML SOLUTION;PERFUSION, CARDIAC Prescription AT 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
02/26/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
12/12/2000 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1999 SUPPL-34 Labeling

Label is not available on this site.

11/14/1997 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/16/2002 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18608slr031ltr.pdf
03/20/1997 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1992 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

11/26/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1985 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1985 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1987 SUPPL-10 Labeling

Label is not available on this site.

09/13/1989 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1984 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1982 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1982 SUPPL-1 Labeling

Label is not available on this site.

PLEGISOL IN PLASTIC CONTAINER

SOLUTION;PERFUSION, CARDIAC; 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIOPLEGIC IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML SOLUTION;PERFUSION, CARDIAC Prescription No AT 075323 BAXTER HLTHCARE
PLEGISOL IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML SOLUTION;PERFUSION, CARDIAC Prescription Yes AT 018608 HOSPIRA

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