| METHYLPHENIDATE HYDROCHLORIDE |
214202 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
30MG |
No
|
No
|
2023/02/07
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| METHYLPHENIDATE HYDROCHLORIDE |
214202 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
40MG |
No
|
No
|
2023/02/07
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| METHYLPHENIDATE HYDROCHLORIDE |
214447 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
No
|
No
|
2023/05/23
|
2023/05/23
|
ALKEM LABS LTD |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
214447 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
No
|
No
|
2023/05/23
|
2023/05/23
|
ALKEM LABS LTD |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
214447 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
No
|
No
|
2023/05/23
|
2023/05/23
|
ALKEM LABS LTD |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
214447 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
No
|
No
|
2023/05/23
|
2023/05/23
|
ALKEM LABS LTD |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
217229 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
72MG |
No
|
No
|
2023/08/25
|
2023/08/25
|
SUN PHARM INDS INC |
Prescription |