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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020675
Company: ABBVIE

Products on NDA 020675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
URSO 250	URSODIOL	250MG	TABLET;ORAL	Discontinued	None	Yes	No
URSO FORTE	URSODIOL	500MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020675

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2023	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020675s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020675Orig1s028ltr.pdf
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.

Labels for NDA 020675

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020675s028lbl.pdf
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

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