Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;110MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;200MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;330MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
02/24/1978 | 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 |
---|---|---|---|---|---|
09/11/1990 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/24/1985 | SUPPL-18 | Labeling |
Label is not available on this site. |
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04/03/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/15/1985 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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05/17/1985 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/18/1986 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/26/1981 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1983 | SUPPL-12 | Labeling |
Label is not available on this site. |
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10/24/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/06/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/16/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/12/1980 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/09/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/16/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/08/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/26/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/29/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/29/1978 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/31/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |