Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below| Date | Submission | Status | Documents |
|---|
| Jun 20, 2018 | 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 |
All 3 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Jan 22, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 16, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 20, 2018 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 205622
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
