Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018256
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;5GM/100ML;30MG/100ML;860MG/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
08/28/1979 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/24/1985 SUPPL-11 Labeling

Label is not available on this site.

04/03/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/28/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/26/1981 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-6 Labeling

Label is not available on this site.

10/24/1980 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/17/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/19/1980 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