Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017378
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML INJECTABLE;INJECTION Prescription None Yes Yes
PLASMA-LYTE A IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/02/1979 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
08/05/2019 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017378s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017378Orig1s075ltr.pdf
04/28/2016 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

01/26/2016 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

09/11/2013 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017378Orig1s068,017385Orig1s059ltr.pdf
01/27/2009 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017451s060,017378s065ltr.pdf
08/14/2001 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/01/2001 SUPPL-58 Labeling

Label is not available on this site.

11/24/1999 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2002 SUPPL-55 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-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1990 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1985 SUPPL-40 Labeling

Label is not available on this site.

06/13/1985 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1984 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1985 SUPPL-35 Labeling

Label is not available on this site.

08/28/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1982 SUPPL-30 Labeling

Label is not available on this site.

11/22/1982 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1982 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-25 Labeling

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.

09/03/1981 SUPPL-17 Labeling

Label is not available on this site.

09/03/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1979 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/05/2019 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017378s075lbl.pdf
09/11/2013 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf
01/27/2009 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf

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