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. |