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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019047
Company: BAXTER HLTHCARE

Products on NDA 019047

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019047

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.

Labels for NDA 019047

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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