Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019870
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML INJECTABLE;INJECTION 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
06/10/1993 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
05/11/2004 SUPPL-9 Labeling

Label is not available on this site.

07/01/2002 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2000 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/15/2000 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/13/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/01/1994 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English