Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074700
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription AB No No
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription AB No No
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/21/1996 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
04/06/2020 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/20/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/19/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/06/2003 SUPPL-6 Labeling

Label is not available on this site.

10/11/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

02/02/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

09/23/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/16/1998 SUPPL-2 Labeling

Label is not available on this site.

06/09/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BUMETANIDE

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 209724 AMNEAL PHARMS CO
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 074225 HERITAGE PHARMA
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 074700 SANDOZ
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 209916 UPSHER SMITH LABS
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 202900 ZYDUS PHARMS
BUMEX BUMETANIDE 0.5MG TABLET;ORAL Prescription Yes AB 018225 VALIDUS PHARMS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 209724 AMNEAL PHARMS CO
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 074225 HERITAGE PHARMA
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 074700 SANDOZ
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 209916 UPSHER SMITH LABS
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 202900 ZYDUS PHARMS
BUMEX BUMETANIDE 1MG TABLET;ORAL Prescription Yes AB 018225 VALIDUS PHARMS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 209724 AMNEAL PHARMS CO
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 074225 HERITAGE PHARMA
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 074700 SANDOZ
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 209916 UPSHER SMITH LABS
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 202900 ZYDUS PHARMS
BUMEX BUMETANIDE 2MG TABLET;ORAL Prescription Yes AB 018225 VALIDUS PHARMS

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