Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018252
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOLYTE S IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/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
08/05/1980 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-16 Manufacturing (CMC)

Label is not available on this site.

10/06/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/04/1985 SUPPL-13 Labeling

Label is not available on this site.

04/03/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/05/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/28/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/17/1983 SUPPL-8 Labeling

Label is not available on this site.

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

Label is not available on this site.

12/10/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/15/1981 SUPPL-5 Labeling

Label is not available on this site.

12/10/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

11/24/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/07/1980 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