Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
| DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/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 |
|---|---|---|---|---|---|---|---|
| 10/29/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/05/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/03/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/09/1998 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/26/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/13/1995 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/05/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/11/1990 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/13/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/19/1988 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/09/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/10/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/05/1987 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/29/1986 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 01/29/1986 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/03/1985 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/17/1985 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/31/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/31/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/24/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/02/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/02/1983 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/08/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/16/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/16/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/25/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/26/1982 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |