Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019077
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A 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
03/02/1984 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
09/11/1990 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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