Rivastigmine
ANDA 215445, held by Yichang Humanwell. Rivastigmine.
- First approved: Sep 23, 2025
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2025 | Original application | Approved | None posted |
Products
3 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Rivastigmine4.6MG/24HR · film, extended release;transdermal | Rivastigmine | Rx |
| Rivastigmine9.5MG/24HR · film, extended release;transdermal | Rivastigmine | Rx |
| Rivastigmine13.3MG/24HR · film, extended release;transdermal | Rivastigmine | Rx |
Identifiers
- Application
- ANDA 215445
- Drugs@FDA
- Overview at FDA
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