Approvals and New Uses
The original application and every efficacy supplement, newest first; all 6 submissions below| Date | Submission | Status | Documents |
|---|
| Sep 3, 2015 | Original application | Approved | None posted |
| Aug 31, 2015 | Original application | Approved | ReviewLetterLetter |
Products
3 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Rivastigmine4.6MG/24HR · film, extended release;transdermal | Rivastigmine | Discontinued |
| Rivastigmine9.5MG/24HR · film, extended release;transdermal | Rivastigmine | Discontinued |
| Rivastigmine13.3MG/24HR · film, extended release;transdermal | Rivastigmine | Discontinued |
All 6 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Dec 4, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 4, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 24, 2016 | Supplement 1Manufacturing | Approved | None posted |
| Feb 24, 2016 | Supplement 2Manufacturing | Approved | None posted |
| Sep 3, 2015 | Original application | Approved | None posted |
| Aug 31, 2015 | Original application | Approved | ReviewLetterLetter |
Identifiers
- Application
- ANDA 204403
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
