Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213504
Company: STRIDES PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
URSODIOL URSODIOL 250MG TABLET;ORAL Prescription AB No No
URSODIOL URSODIOL 500MG 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
08/20/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

URSODIOL

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
URSO 250 URSODIOL 250MG TABLET;ORAL Prescription Yes AB 020675 ALLERGAN
URSODIOL URSODIOL 250MG TABLET;ORAL Prescription No AB 090801 GLENMARK GENERICS
URSODIOL URSODIOL 250MG TABLET;ORAL Prescription No AB 202540 PAR PHARM
URSODIOL URSODIOL 250MG TABLET;ORAL Prescription No AB 213504 STRIDES PHARMA
URSODIOL URSODIOL 250MG TABLET;ORAL Prescription No AB 211145 ZYDUS

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
URSO FORTE URSODIOL 500MG TABLET;ORAL Prescription Yes AB 020675 ALLERGAN
URSODIOL URSODIOL 500MG TABLET;ORAL Prescription No AB 090801 GLENMARK GENERICS
URSODIOL URSODIOL 500MG TABLET;ORAL Prescription No AB 202540 PAR PHARM
URSODIOL URSODIOL 500MG TABLET;ORAL Prescription No AB 213504 STRIDES PHARMA
URSODIOL URSODIOL 500MG TABLET;ORAL Prescription No AB 211145 ZYDUS

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