Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019047
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLASMA-LYTE 56 IN PLASTIC CONTAINER MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE 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
06/15/1984 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
08/24/2005 SUPPL-24 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf
08/14/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/01/2001 SUPPL-20 Labeling

Label is not available on this site.

11/24/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/03/2002 SUPPL-18 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-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1985 SUPPL-2 Labeling

Label is not available on this site.

07/11/1985 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
08/24/2005 SUPPL-24 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf

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