Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RENAMIN W/O ELECTROLYTES | AMINO ACIDS | 6.5% (6.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| TRAVASOL 10% W/O ELECTROLYTES | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| TRAVASOL 3.5% W/ ELECTROLYTES | 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 |
| TRAVASOL 5.5% W/ ELECTROLYTES | 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 5.5% W/O ELECTROLYTES | AMINO ACIDS | 5.5% (5.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| TRAVASOL 8.5% W/ ELECTROLYTES | 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 |
| TRAVASOL 8.5% W/O ELECTROLYTES | AMINO ACIDS | 8.5% (8.5GM/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 |
|---|---|---|---|---|---|---|---|
| 03/24/1976 | 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 |
|---|---|---|---|---|---|
| 01/17/2003 | SUPPL-67 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493scs067ltr.pdf |
| 04/30/2003 | SUPPL-66 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr066ltr.pdf |
| 01/03/2003 | SUPPL-65 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr065ltr.pdf |
| 03/31/1999 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1999 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1992 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1992 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1993 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1990 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1993 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 04/30/1997 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1987 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/18/1987 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1982 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1982 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/1981 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1982 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/15/1982 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1979 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/28/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/28/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1977 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/18/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1977 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1977 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1977 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/07/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/24/1976 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/19/1976 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |