DAPAGLIFLOZIN |
211442 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211442 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2019/01/04
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211439 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2019/01/18
(TA)
|
--
|
HETERO LABS UNIT III |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211439 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2019/01/18
(TA)
|
--
|
HETERO LABS UNIT III |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211541 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2019/02/04
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211541 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2019/02/04
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211564 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2020/03/20
(TA)
|
--
|
GLENMARK GENERICS |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211564 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2020/03/20
(TA)
|
--
|
GLENMARK GENERICS |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211479 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
5MG; 500MG |
No
|
No
|
2020/05/01
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211479 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
5MG; 1GM |
No
|
No
|
2020/05/01
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211479 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
10MG; 500MG |
No
|
No
|
2020/05/01
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211479 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
10MG; 1GM |
No
|
No
|
2020/05/01
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN AND SAXAGLIPTIN |
211533 |
001 |
ANDA |
DAPAGLIFLOZIN; SAXAGLIPTIN |
TABLET; ORAL |
10MG/5MG |
No
|
No
|
2020/05/28
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211478 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2021/02/26
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211478 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2021/02/26
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
216119 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2022/08/01
(TA)
|
--
|
JIANGSU HANSOH PHARM |
None (Tentative Approval) |
DAPAGLIFLOZIN |
216119 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2022/08/01
(TA)
|
--
|
JIANGSU HANSOH PHARM |
None (Tentative Approval) |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
001 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG/1000MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
002 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG/500MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
003 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG/1000MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |