Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020173
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/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 |
|---|---|---|---|---|---|---|---|
| 10/27/1995 | 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 |
|---|---|---|---|---|---|
| 10/29/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 06/09/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/21/2000 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 02/28/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/30/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |