Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018376
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/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 |
---|---|---|---|---|---|---|---|
07/11/1980 | 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-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/24/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
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04/03/1985 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/28/1985 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/18/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/26/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/10/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/12/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/24/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |