Drugs@FDA: FDA Approved Drug Products

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

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