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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018840
Company: BAXTER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND ELECTROLYTE NO. 75 IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE 5GM/100ML;205MG/100ML;100MG/100ML;120MG/100ML;220MG/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
06/29/1983 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
08/26/2005 SUPPL-29 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
06/07/2005 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018840s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018840s028ltr.pdf
08/14/2001 SUPPL-25 Manufacturing (CMC)

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

Label is not available on this site.
11/29/2000 SUPPL-23 Labeling

Label is not available on this site.
04/29/1997 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/18/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
09/30/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
04/26/1991 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
04/29/1991 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
03/26/1991 SUPPL-16 Manufacturing (CMC)-Control

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

Label is not available on this site.
07/26/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
01/12/1989 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
07/25/1987 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/28/1987 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1986 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/26/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
04/17/1985 SUPPL-4 Labeling

Label is not available on this site.
06/13/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
09/22/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
06/24/1985 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
08/26/2005 SUPPL-29 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf
06/07/2005 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018840s028lbl.pdf
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