Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074225
Company: HERITAGE PHARMA
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 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
04/24/1995 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-21 Labeling-Package Insert

Label is not available on this site.

04/06/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

03/03/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/03/2008 SUPPL-16 Labeling

Label is not available on this site.

01/21/2005 SUPPL-9 Labeling

Label is not available on this site.

07/29/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

02/21/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

01/14/1999 SUPPL-1 Labeling

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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