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Abbreviated New Drug Application (ANDA): 075517
Company: EPIC PHARMA
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
03/14/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75517ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75517_Ursodiol.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2015 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/30/2007 SUPPL-6 Labeling

Label is not available on this site.

04/11/2005 SUPPL-4 Labeling

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 TEVA BRANDED PHARM
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 214849 AUROBINDO PHARMA LTD
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 213555 CHARTWELL RX
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 210344 STRIDES PHARMA
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 075592 TEVA PHARMS
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 214295 ZYDUS
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