Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074332
Company: HOSPIRA

Products on ANDA 074332

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074332

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.

Therapeutic Equivalents for ANDA 074332

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	216434	GLAND PHARMA LTD
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074332	HOSPIRA
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215364	MSN
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074441	SAGENT
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	079196	WEST-WARD PHARMS INT