Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020177
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/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 |
---|---|---|---|---|---|---|---|
10/23/1995 | 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-11 | Labeling |
Label is not available on this site. |
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08/29/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/09/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
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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07/10/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/28/2000 | SUPPL-5 | Manufacturing (CMC)-Packaging |
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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06/11/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1997 | 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. |