Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212019
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription BX No No
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription BX No No
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription BX 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
12/12/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

BUMETANIDE

There are no Therapeutic Equivalents.

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