Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019395
Company: FRESENIUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL 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
03/26/1986 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
09/27/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1992 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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