Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016080
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANNITOL 10% MANNITOL 10GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER MANNITOL 10GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 15% MANNITOL 15GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% MANNITOL 15GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 20% MANNITOL 20GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 5% MANNITOL 5GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% MANNITOL 5GM/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
10/08/1965 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
05/24/1985 SUPPL-14 Labeling

Label is not available on this site.

05/16/1985 SUPPL-13 Labeling

Label is not available on this site.

04/06/1985 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/09/1984 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1981 SUPPL-7 Labeling

Label is not available on this site.

05/24/1982 SUPPL-6 Labeling

Label is not available on this site.

12/17/1981 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/01/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1977 SUPPL-3 Labeling

Label is not available on this site.

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