Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019319
Company: BAXTER HLTHCARE

Products on NDA 019319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION FOR SLUSH;IRRIGATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1985	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
09/29/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/15/2007	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/14/2001	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/07/2000	SUPPL-8	Labeling		Label is not available on this site.
02/18/1994	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/1994	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/02/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/26/1991	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/1990	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/1989	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.