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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017385
Company: BAXTER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE 5GM/100ML;32MG/100ML;128MG/100ML;234MG/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
07/11/2018 SUPPL-64 Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf
03/18/2016 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017385s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017385Orig1s062ltr.pdf
12/22/2014 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017385s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017385Orig1s060ltr.pdf
09/11/2013 SUPPL-59 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
08/14/2001 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.
02/01/2001 SUPPL-51 Labeling

Label is not available on this site.
11/24/1999 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.
11/29/2000 SUPPL-49 Labeling

Label is not available on this site.
04/29/1997 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/18/1994 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.
09/30/1994 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.
04/29/1991 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.
01/10/1991 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.
03/26/1991 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/1991 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
07/26/1989 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.
07/25/1987 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/28/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1986 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/15/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.
04/18/1985 SUPPL-34 Labeling

Label is not available on this site.
06/13/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
09/22/1984 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
02/28/1984 SUPPL-31 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.
08/28/1985 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
03/16/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
01/24/1985 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
02/16/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
07/11/1983 SUPPL-23 Labeling

Label is not available on this site.
11/20/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
06/03/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
04/16/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
08/26/1981 SUPPL-18 Labeling

Label is not available on this site.
12/21/1981 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
06/29/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
01/21/1981 SUPPL-14 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.
08/06/1980 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.
05/30/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
06/18/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
08/10/1979 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.
06/28/1980 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/18/2016 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017385s062lbl.pdf
12/22/2014 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017385s060lbl.pdf
09/11/2013 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf
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