Methylphenidate
ANDA 210924, held by Actavis Elizabeth. Methylphenidate.
- First approved: Jun 19, 2020
- 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 |
|---|---|---|---|
| Jun 19, 2020 | Original application | Approved |
Products
3 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Methylphenidate8.6MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | Rx |
| Methylphenidate17.3MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | Rx |
| Methylphenidate25.9MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | Rx |
Identifiers
- Application
- ANDA 210924
- Drugs@FDA
- Overview at FDA
- Company
- Actavis Elizabeth
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