Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075592
Company: TEVA PHARMS
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
05/25/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75592ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-592_Ursodiol.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/29/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-1 Manufacturing (CMC)-Facility

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 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 214329 VGYAAN
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 214295 ZYDUS

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