Application 204629

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JARDIANCE	EMPAGLIFLOZIN	TABLET;ORAL	10MG	Yes	No
002	JARDIANCE	EMPAGLIFLOZIN	TABLET;ORAL	25MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4492	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4492	JARDIANCE	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4492	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health 107, LLC	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health 107, LLC	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
71610-177	Jardiance	Empagliflozin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-177	Jardiance	Empagliflozin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83951	SUPPL	2025-10-28
83924	SUPPL	2025-10-27
83923	SUPPL	2025-10-27
75559	SUPPL	2023-09-25
75532	SUPPL	2023-09-22
75438	SUPPL	2023-09-13
75414	SUPPL	2023-09-13
74588	SUPPL	2023-06-22
74575	SUPPL	2023-06-21
73523	SUPPL	2023-02-16
72380	SUPPL	2022-10-17
72379	SUPPL	2022-10-17
72337	SUPPL	2022-10-14
70618	SUPPL	2022-03-28
70617	SUPPL	2022-03-28
70580	SUPPL	2022-03-22
70277	SUPPL	2022-02-28
70276	SUPPL	2022-02-28
70270	SUPPL	2022-02-28
68418	SUPPL	2021-08-19
68417	SUPPL	2021-08-19
68411	SUPPL	2021-08-19
67800	SUPPL	2021-06-15
67799	SUPPL	2021-06-15
67782	SUPPL	2021-06-14
67781	SUPPL	2021-06-14
67780	SUPPL	2021-06-14
65830	SUPPL	2021-01-06
65829	SUPPL	2021-01-06
64668	SUPPL	2020-09-24
64667	SUPPL	2020-09-24
64666	SUPPL	2020-09-24
64011	SUPPL	2020-07-22
61672	SUPPL	2020-01-27
61664	SUPPL	2020-01-27
61663	SUPPL	2020-01-27
57065	SUPPL	2018-12-30
57018	SUPPL	2018-12-26
57017	SUPPL	2018-12-26
56175	SUPPL	2018-10-30
56158	SUPPL	2018-10-29
56157	SUPPL	2018-10-29
50715	SUPPL	2017-12-15
50692	SUPPL	2017-12-14
46031	SUPPL	2016-12-06
46011	SUPPL	2016-12-05
10369	SUPPL	2016-07-12
19580	SUPPL	2016-03-22
10368	SUPPL	2016-03-22
19579	SUPPL	2016-03-04
32575	SUPPL	2016-02-09
32576	SUPPL	2015-12-08
19581	SUPPL	2015-12-08
40402	SUPPL	2015-07-01
40401	SUPPL	2015-07-01
19578	SUPPL	2015-07-01
32574	SUPPL	2015-06-30
32573	SUPPL	2015-06-30
10367	SUPPL	2015-06-30
43470	ORIG	2014-09-09
24474	ORIG	2014-09-09
32572	ORIG	2014-08-04
19577	ORIG	2014-08-04

Application 204629

Related Records#

Application Products#

NDC Listings For This Application#

Documents#