Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018379
Company: FRESENIUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/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
09/03/1980 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-96 Manufacturing (CMC)

Label is not available on this site.

11/09/2001 SUPPL-95 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/14/1997 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1996 SUPPL-92 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1996 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

01/23/1996 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1991 SUPPL-85 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-84 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

08/01/1990 SUPPL-80 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/22/1990 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

06/14/1989 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1988 SUPPL-77 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/02/1988 SUPPL-76 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/24/1988 SUPPL-74 Labeling

Label is not available on this site.

06/24/1988 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

06/24/1988 SUPPL-72 Labeling

Label is not available on this site.

06/24/1988 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1987 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1987 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1987 SUPPL-64 Labeling

Label is not available on this site.

04/28/1987 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1987 SUPPL-62 Labeling

Label is not available on this site.

02/27/1987 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1986 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1985 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1986 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1986 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1986 SUPPL-56 Labeling

Label is not available on this site.

01/18/1986 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1986 SUPPL-54 Labeling

Label is not available on this site.

01/18/1986 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/1986 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1985 SUPPL-51 Labeling

Label is not available on this site.

10/02/1985 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1985 SUPPL-49 Labeling

Label is not available on this site.

10/24/1985 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1985 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1985 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1985 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/02/1985 SUPPL-44 Labeling

Label is not available on this site.

10/02/1985 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1985 SUPPL-42 Labeling

Label is not available on this site.

12/10/1985 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1984 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1985 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/01/1985 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1985 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1984 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1984 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1989 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1985 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1984 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1982 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1984 SUPPL-22 Labeling

Label is not available on this site.

10/10/1984 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/05/1983 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/04/1982 SUPPL-19 Labeling

Label is not available on this site.

07/04/1982 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/09/1982 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/07/1982 SUPPL-16 Labeling

Label is not available on this site.

07/07/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1982 SUPPL-14 Labeling

Label is not available on this site.

08/05/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1982 SUPPL-10 Labeling

Label is not available on this site.

03/11/1982 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/09/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1981 SUPPL-7 Labeling

Label is not available on this site.

04/23/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1982 SUPPL-3 Labeling

Label is not available on this site.

01/19/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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