Drugs@FDA: FDA-Approved Drugs
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. |
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11/09/2001 | SUPPL-95 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/14/1997 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
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07/03/1996 | SUPPL-93 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/01/1996 | SUPPL-92 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/07/1996 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
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01/23/1996 | SUPPL-89 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/30/1991 | SUPPL-85 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/28/1992 | SUPPL-84 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/10/1991 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/11/1990 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/1990 | SUPPL-80 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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02/22/1990 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
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06/14/1989 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/24/1988 | SUPPL-77 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/02/1988 | SUPPL-76 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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06/24/1988 | SUPPL-74 | Labeling |
Label is not available on this site. |
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06/24/1988 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
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06/24/1988 | SUPPL-72 | Labeling |
Label is not available on this site. |
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06/24/1988 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
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07/30/1987 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/26/1986 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/08/1986 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/11/1987 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/11/1987 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/28/1987 | SUPPL-64 | Labeling |
Label is not available on this site. |
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04/28/1987 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1987 | SUPPL-62 | Labeling |
Label is not available on this site. |
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02/27/1987 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/21/1986 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/06/1985 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/26/1986 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/26/1986 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/18/1986 | SUPPL-56 | Labeling |
Label is not available on this site. |
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01/18/1986 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/18/1986 | SUPPL-54 | Labeling |
Label is not available on this site. |
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01/18/1986 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/31/1986 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/02/1985 | SUPPL-51 | Labeling |
Label is not available on this site. |
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10/02/1985 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/24/1985 | SUPPL-49 | Labeling |
Label is not available on this site. |
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10/24/1985 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/02/1985 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/06/1985 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/02/1985 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/1985 | SUPPL-44 | Labeling |
Label is not available on this site. |
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10/02/1985 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/10/1985 | SUPPL-42 | Labeling |
Label is not available on this site. |
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12/10/1985 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/22/1984 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/26/1985 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/01/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/29/1985 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/28/1984 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/08/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/08/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/22/1989 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/17/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/21/1984 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/15/1985 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/25/1984 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/25/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/17/1984 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/26/1982 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/21/1982 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/01/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/10/1984 | SUPPL-22 | Labeling |
Label is not available on this site. |
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10/10/1984 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/05/1983 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/04/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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07/04/1982 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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06/09/1982 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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07/07/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
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07/07/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/05/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
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08/05/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/01/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/08/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/11/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/11/1982 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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06/09/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/01/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
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04/23/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/16/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/09/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/19/1981 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/31/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |