Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018336
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

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