PALBOCICLIB |
213107 |
001 |
ANDA |
PALBOCICLIB |
CAPSULE; ORAL |
75MG |
No
|
No
|
2021/04/30
(TA)
|
--
|
SUN PHARM INDS LTD |
None (Tentative Approval) |
PALBOCICLIB |
213107 |
002 |
ANDA |
PALBOCICLIB |
CAPSULE; ORAL |
100MG |
No
|
No
|
2021/04/30
(TA)
|
--
|
SUN PHARM INDS LTD |
None (Tentative Approval) |
PALBOCICLIB |
213107 |
003 |
ANDA |
PALBOCICLIB |
CAPSULE; ORAL |
125MG |
No
|
No
|
2021/04/30
(TA)
|
--
|
SUN PHARM INDS LTD |
None (Tentative Approval) |
PALBOCICLIB |
213091 |
001 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
75MG |
No
|
No
|
2021/08/18
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
PALBOCICLIB |
213091 |
002 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
100MG |
No
|
No
|
2021/08/18
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
PALBOCICLIB |
213091 |
003 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
125MG |
No
|
No
|
2021/08/18
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
PALBOCICLIB |
213152 |
002 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
100MG |
No
|
No
|
2022/03/04
(TA)
|
--
|
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD |
None (Tentative Approval) |
PALBOCICLIB |
213152 |
003 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
125MG |
No
|
No
|
2022/03/04
(TA)
|
--
|
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD |
None (Tentative Approval) |
PALBOCICLIB |
213086 |
002 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
100MG |
No
|
No
|
2022/07/07
(TA)
|
--
|
EUGIA PHARMA SPECLTS |
None (Tentative Approval) |
PALBOCICLIB |
213086 |
003 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
125MG |
No
|
No
|
2022/07/07
(TA)
|
--
|
EUGIA PHARMA SPECLTS |
None (Tentative Approval) |
PALBOCICLIB |
214758 |
001 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
75MG |
No
|
No
|
2023/04/12
(TA)
|
--
|
MSN PHARMACEUTICALS INC |
None (Tentative Approval) |
PALBOCICLIB |
214758 |
002 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
100MG |
No
|
No
|
2023/04/12
(TA)
|
--
|
MSN PHARMACEUTICALS INC |
None (Tentative Approval) |
PALBOCICLIB |
214758 |
003 |
ANDA |
PALBOCICLIB |
CAPSULE;ORAL |
125MG |
No
|
No
|
2023/04/12
(TA)
|
--
|
MSN PHARMACEUTICALS INC |
None (Tentative Approval) |
PALBOCICLIB |
215570 |
001 |
ANDA |
PALBOCICLIB |
TABLET;ORAL |
75MG |
No
|
No
|
2024/06/05
|
2024/06/05
|
SYNTHON PHARMS INC |
Discontinued |
PALBOCICLIB |
215570 |
002 |
ANDA |
PALBOCICLIB |
TABLET;ORAL |
100MG |
No
|
No
|
2024/06/05
|
2024/06/05
|
SYNTHON PHARMS INC |
Discontinued |
PALBOCICLIB |
215570 |
003 |
ANDA |
PALBOCICLIB |
TABLET;ORAL |
125MG |
No
|
No
|
2024/06/05
|
2024/06/05
|
SYNTHON PHARMS INC |
Discontinued |