Ursodiol
ANDA 210344, held by Strides Pharma. Ursodiol.
- First approved: Jan 22, 2021
- Review: Standard
- Supplements approved: 2
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2021 | Original application | Approved | None posted |
Products
2 strengths and formsAll 3 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 25, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 22, 2021 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 210344
- Drugs@FDA
- Overview at FDA
- Company
- Strides Pharma Inc
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters