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BUMETANIDE از شرکت AMNEAL PHARMS CO

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BUMETANIDE از شرکت AMNEAL PHARMS CO

Abbreviated New Drug Application (ANDA): 209724

Company: AMNEAL PHARMS CO

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
10/18/2017 ORIG-1 Approval

STANDARD

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 212019 RISING
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 212019 RISING
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 212019 RISING
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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