Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAVASOL 10% IN PLASTIC CONTAINER | AMINO ACIDS | 10% (10MG/100ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| TRAVASOL 5.5% IN PLASTIC CONTAINER | AMINO ACIDS | 5.5% (5.5GM/100ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| TRAVASOL 8.5% IN PLASTIC CONTAINER | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 08/23/1984 | 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 |
|---|---|---|---|---|---|
| 09/23/2020 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018931s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018931Orig1s055, 020849Orig1s025ltr.pdf | |
| 01/15/2016 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/2017 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018931s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018931Orig1s049ltr.pdf | |
| 02/03/2015 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/2014 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/2003 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-33 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-32 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/24/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/26/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/23/2020 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018931s055lbl.pdf | |
| 11/16/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018931s049lbl.pdf |