Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019024
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHYSIOLYTE IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML SOLUTION;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
06/08/1984 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
05/08/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/22/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19024slr015ltr.pdf
07/08/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1990 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1988 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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