Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020675
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
URSO 250 URSODIOL 250MG TABLET;ORAL Prescription AB Yes No
URSO FORTE URSODIOL 500MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/10/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20675a.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2021 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020675s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020675Orig1s027ltr.pdf
09/11/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/21/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/19/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/14/2013 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020675s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020675Orig1s022ltr.pdf
02/27/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/25/2009 SUPPL-17 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf
03/10/2008 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020675s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020675s013ltr.pdf
09/24/2004 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20675s011ltr.pdf
07/21/2004 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20675s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20675s009ltr.pdf
03/08/2001 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20675s7ltr.pdf
03/08/2001 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20675s7ltr.pdf
01/30/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/02/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/07/2021 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020675s027lbl.pdf
06/14/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020675s022lbl.pdf
11/25/2009 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf
03/10/2008 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020675s013lbl.pdf
07/21/2004 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20675s009lbl.pdf

URSO 250

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

URSO FORTE

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English