| METHYLPHENIDATE HYDROCHLORIDE |
076772 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
No
|
No
|
2018/03/22
|
2018/03/22
|
ACTAVIS LABS FL |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
076772 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
No
|
No
|
2018/03/22
|
2018/03/22
|
ACTAVIS LABS FL |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
076772 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
No
|
No
|
2018/03/22
|
2018/03/22
|
ACTAVIS LABS FL |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
076772 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
No
|
No
|
2018/03/22
|
--
|
ACTAVIS LABS FL |
None (Tentative Approval) |
| METHYLPHENIDATE HYDROCHLORIDE |
206049 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
FOR SUSPENSION, EXTENDED RELEASE;ORAL |
5MG/ML |
No
|
No
|
2018/05/17
|
2018/05/17
|
ACTAVIS LABS FL INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
209211 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
No
|
No
|
2018/09/19
|
2018/09/19
|
CEDIPROF INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
209211 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
No
|
No
|
2018/09/19
|
2018/09/19
|
CEDIPROF INC |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
210139 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
No
|
No
|
2018/10/03
|
2018/10/03
|
HIBROW HLTHCARE |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
210139 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
No
|
No
|
2018/10/03
|
2018/10/03
|
HIBROW HLTHCARE |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
004 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
20MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
006 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| DEXMETHYLPHENIDATE HYDROCHLORIDE |
210279 |
008 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
No
|
No
|
2018/10/09
|
2018/10/09
|
ADARE PHARMS INC |
Prescription |
| METHYLPHENIDATE HYDROCHLORIDE |
209276 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
No
|
No
|
2018/10/25
|
2018/10/25
|
AUROLIFE PHARMA LLC |
Discontinued |
| METHYLPHENIDATE HYDROCHLORIDE |
209276 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
No
|
No
|
2018/10/25
|
2018/10/25
|
AUROLIFE PHARMA LLC |
Discontinued |
| METHYLPHENIDATE HYDROCHLORIDE |
209276 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
No
|
No
|
2018/10/25
|
2018/10/25
|
AUROLIFE PHARMA LLC |
Discontinued |