Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091112
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINO ACIDS AMINO ACIDS 15%(150GM/1000ML) INJECTABLE;INJECTION Prescription None No No
AMINO ACIDS AMINO ACIDS 15%(300GM/2000ML) INJECTABLE;INJECTION Prescription 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
04/13/2012 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
01/25/2015 SUPPL-2 Labeling

Label is not available on this site.

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