Application Sponsors
ANDA 214202 | TEVA PHARMS USA | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 20MG | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
002 | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 30MG | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
003 | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 40MG | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-05-13 | STANDARD |
Submissions Property Types
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 214202
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)