Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIS-U-SOL IN PLASTIC CONTAINER | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | SOLUTION;IRRIGATION | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/1981 | 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-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/24/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
TIS-U-SOL IN PLASTIC CONTAINER
SOLUTION;IRRIGATION; 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TIS-U-SOL | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018508 | BAXTER HLTHCARE |
| TIS-U-SOL IN PLASTIC CONTAINER | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018336 | BAXTER HLTHCARE |