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FDA ANDA · ANDA074441

BUMETANIDE

Sponsor: SAGENT

APPLICATION
ANDA074441
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-27
LATEST ACTION
2010-03-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUMETANIDEPrescription
BUMETANIDE 0.25MG/ML · INJECTABLE · INJECTION

Approval history

2010-03-08Labeling · Supplement 12AP
2001-04-03Manufacturing (CMC) · Supplement 9AP
1998-11-20Labeling · Supplement 8AP
1998-08-28Manufacturing (CMC) · Supplement 7AP
1997-07-08Manufacturing (CMC) · Supplement 6AP
1997-07-08Manufacturing (CMC) · Supplement 4AP
1997-07-08Manufacturing (CMC) · Supplement 5AP
1996-09-05Manufacturing (CMC) · Supplement 2AP
1996-09-05Manufacturing (CMC) · Supplement 3AP
1995-05-24Labeling · Supplement 1AP
1995-01-27OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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