Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019594
Company: TEVA BRANDED PHARM

Products on NDA 19594

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACTIGALL	URSODIOL	150MG	CAPSULE;ORAL	Discontinued	None	No	No
ACTIGALL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 019594

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2023	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019594s037lbl.pdf
08/14/2002	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019594s21lbl.pdf