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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019594
Company: TEVA BRANDED PHARM
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/14/2002 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019594s21lbl.pdf
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