Drugs@FDA: FDA Approved Drug Products

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

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