Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019025
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE | 5GM/100ML;31MG/100ML;130MG/100ML;26MG/100ML;320MG/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 |
|---|---|---|---|---|---|---|---|
| 12/27/1984 | 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-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/29/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 07/09/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/18/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |