Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019594
Company: TEVA BRANDED PHARM
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 |
---|---|---|---|---|---|
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 |