Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018026
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/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 |
|---|---|---|---|---|---|---|---|
| 02/08/1978 | ORIG-1 | Approval |
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-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/03/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1986 | SUPPL-14 | Manufacturing (CMC) |
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) |
Label is not available on this site. |
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| 08/06/1980 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1980 | SUPPL-9 | Manufacturing (CMC) |
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) |
Label is not available on this site. |
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| 06/08/1979 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1978 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1978 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 03/23/1978 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |