Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018722
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 75MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 220MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/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 |
---|---|---|---|---|---|---|---|
11/09/1982 | 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-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/24/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/03/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |