Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074332
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE;INJECTION Prescription AP 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
10/31/1994 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
07/01/2020 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

01/27/2005 SUPPL-8 Labeling

Label is not available on this site.

02/14/2001 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/01/1998 SUPPL-4 Labeling

Label is not available on this site.

07/09/1997 SUPPL-3 Labeling

Label is not available on this site.

07/09/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BUMETANIDE

INJECTABLE;INJECTION; 0.25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE;INJECTION Prescription No AP 074332 HOSPIRA
BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE;INJECTION Prescription No AP 079196 WEST-WARD PHARMS INT

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