Approvals and New Uses
The original application and every efficacy supplement, newest first; all 4 submissions below| Date | Submission | Status | Documents |
|---|
| Mar 14, 2022 | Original application | Approved | ReviewLetter |
Products
4 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Methylphenidate10MG/9HR (1.1MG/HR) · film, extended release;transdermal | Methylphenidate | Rx |
| Methylphenidate15MG/9HR (1.6MG/HR) · film, extended release;transdermal | Methylphenidate | Rx |
| Methylphenidate20MG/9HR (2.2MG/HR) · film, extended release;transdermal | Methylphenidate | Rx |
| Methylphenidate30MG/9HR (3.3MG/HR) · film, extended release;transdermal | Methylphenidate | Rx |
All 4 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Jul 22, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 22, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 30, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 14, 2022 | Original application | Approved | ReviewLetter |
Identifiers
- Application
- ANDA 206497
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
