Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017438
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLASMA-LYTE R IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;640MG/100ML;496MG/100ML;89.6MG/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
02/01/1979 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-54 Manufacturing (CMC)

Label is not available on this site.

02/01/2001 SUPPL-53 Labeling

Label is not available on this site.

11/24/1999 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/03/2002 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf
04/29/1997 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1991 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1985 SUPPL-35 Labeling

Label is not available on this site.

06/13/1985 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1982 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-24 Labeling

Label is not available on this site.

11/20/1981 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-19 Labeling

Label is not available on this site.

12/21/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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