Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018519
Company: BAXTER HLTHCARE

Products on NDA 018519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRRIGATING SOLUTION G IN PLASTIC CONTAINER	CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE	3.24GM/100ML;380MG/100ML;430MG/100ML	SOLUTION;IRRIGATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/1982	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
03/30/2001	SUPPL-15	Labeling		Label is not available on this site.
07/17/2002	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18519slr014ltr.pdf
09/14/1993	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/1994	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/1990	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/26/1991	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/14/1991	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/26/1989	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
10/30/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/06/1985	SUPPL-4	Labeling		Label is not available on this site.
02/28/1984	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.