| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
004 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
20MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
006 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
215523 |
008 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
No
|
No
|
2021/12/08
|
2021/12/08
|
ASCENT PHARMS INC |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
214111 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
No
|
No
|
2022/05/31
|
2022/05/31
|
RHODES PHARMS |
Discontinued |
| METHYLPHENIDATE HYDROCHLORIDE |
214111 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
No
|
No
|
2022/05/31
|
2022/05/31
|
RHODES PHARMS |
Discontinued |
| METHYLPHENIDATE HYDROCHLORIDE |
214111 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
No
|
No
|
2022/05/31
|
2022/05/31
|
RHODES PHARMS |
Discontinued |
| METHYLPHENIDATE HYDROCHLORIDE |
214111 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
No
|
No
|
2022/05/31
|
2022/05/31
|
RHODES PHARMS |
Discontinued |
| METHYLPHENIDATE HYDROCHLORIDE |
214202 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
20MG |
No
|
No
|
2023/02/07
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| 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 |