Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019718
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOLYTE E IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE 35MG/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/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
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
07/01/2002 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

08/21/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/13/1995 SUPPL-7 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.

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