Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213200
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
URSODIOL URSODIOL 300MG CAPSULE;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
02/12/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

URSODIOL

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIGALL URSODIOL 300MG CAPSULE;ORAL Prescription Yes AB 019594 ALLERGAN
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 210707 ABHAI LLC
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 211301 AMNEAL PHARMS CO
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 075517 EPIC PHARMA
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 212452 EYWA PHARMA
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 079082 LANNETT CO INC
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 090530 MYLAN
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 213200 RISING
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 075592 TEVA PHARMS
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 213555 UPSHER SMITH LABS

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