Application 206497
- Type
- ANDA
- Sponsor
- MYLAN TECH VIATRIS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHYLPHENIDATE | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 10MG/9HR (1.1MG/HR) | No | No |
| 002 | METHYLPHENIDATE | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 15MG/9HR (1.6MG/HR) | No | No |
| 003 | METHYLPHENIDATE | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 20MG/9HR (2.2MG/HR) | No | No |
| 004 | METHYLPHENIDATE | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 30MG/9HR (3.3MG/HR) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-8260 | Methylphenidate | Methylphenidate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8261 | Methylphenidate | Methylphenidate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8262 | Methylphenidate | Methylphenidate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8263 | Methylphenidate | Methylphenidate | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73955 | ORIG | 2023-04-06 |
| 71754 | ORIG | 2022-08-09 |