Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018725
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 20MG/100ML;30MG/100ML;380MG/100ML;600MG/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 |
|---|---|---|---|---|---|---|---|
| 11/29/1982 | 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)-Packaging |
Label is not available on this site. |
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| 05/24/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/03/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/03/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |