Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;10GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;15GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;20GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;25GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;5GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;10GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;15GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;20GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;25GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;5GM/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 |
---|---|---|---|---|---|---|---|
09/23/1988 | 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 |
---|---|---|---|---|---|
08/14/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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03/24/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/24/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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04/12/2000 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19520S18LTR.PDF |
03/31/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/18/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
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04/29/1997 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/18/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/19/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/30/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/24/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1992 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/05/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/04/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/1991 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/26/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |