Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 020374
Company: FRESENIUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;4.25GM/100ML;5.08MG/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
06/13/1994 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
01/10/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/22/2002 SUPPL-7 Labeling

Label is not available on this site.

01/22/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/14/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-3 Labeling

Label is not available on this site.

07/22/1997 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/24/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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