Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019696
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 30MG/100ML;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/29/1989 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
05/14/2004 SUPPL-20 Labeling

Label is not available on this site.

07/01/2002 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2000 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/15/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/12/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/21/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/13/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/21/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/21/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/29/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/12/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/21/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/18/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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