Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018271
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/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 |
|---|---|---|---|---|---|---|---|
| 10/03/1980 | 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 |
|---|---|---|---|---|---|
| 09/11/1990 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/28/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/09/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/14/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/03/1985 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/1985 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/18/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/17/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/26/1981 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/10/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/16/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/30/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/02/1981 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |