Application 125469

Type: BLA
Sponsor: ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125469	Trulicity	dulaglutide	351(a)	Rx	2026-09-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRULICITY	DULAGLUTIDE	INJECTABLE;INJECTION	0.75MG/0.5ML	No	No
002	TRULICITY	DULAGLUTIDE	INJECTABLE;INJECTION	1.5MG/0.5ML	Yes	No
003	TRULICITY	DULAGLUTIDE	INJECTABLE;INJECTION	3MG/0.5ML	No	No
004	TRULICITY	DULAGLUTIDE	INJECTABLE;INJECTION	4.5MG/0.5ML	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trulicity	DULAGLUTIDE	Eli Lilly and Company	463050bd-2b1c-40f5-b3c3-0a04bb433309	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469 ndc (product): 0002-2236 ndc (product): 0002-3182 ndc (product): 0002-1434 ndc (product): 0002-1433
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	af4e38a6-ad3f-480c-ae82-5ac6c7735b99	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
Trulicity	DULAGLUTIDE	A-S Medication Solutions	58353438-3236-4596-9324-62fed9615cb7	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469 ndc (product): 50090-3484 ndc (product): 50090-3483
Trulicity	DULAGLUTIDE	A-S Medication Solutions	6088c732-afa1-4fee-9206-22e52baf4731	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469 ndc (product): 50090-5467
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	0a4716d0-9c9c-4bc3-a8f1-6784599aae89	2023-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	a923e467-fea3-431c-b7e4-c9669af607b7	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	80d1e766-fefc-44b4-bec9-c7b0198ec08f	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1433	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-1434	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-2236	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
0002-3182	Trulicity	Dulaglutide	Eli Lilly and Company	BLA	Current
50090-3483	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3483	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3483	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3483	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3484	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3484	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3484	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3484	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-3484	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-5467	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-5467	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current
50090-5467	Trulicity	Dulaglutide	A-S Medication Solutions	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85385	SUPPL	2026-03-18
85373	SUPPL	2026-03-16
85386	SUPPL	2026-03-12
82377	SUPPL	2025-06-02
82344	SUPPL	2025-05-29
80121	SUPPL	2024-11-05
80116	SUPPL	2024-11-04
80115	SUPPL	2024-11-04
72661	SUPPL	2022-11-21
72660	SUPPL	2022-11-21
72650	SUPPL	2022-11-18
71326	SUPPL	2022-06-15
71325	SUPPL	2022-06-15
71324	SUPPL	2022-06-15
71278	SUPPL	2022-06-13
71277	SUPPL	2022-06-13
68867	SUPPL	2021-10-04
68850	SUPPL	2021-10-01
68849	SUPPL	2021-10-01
64530	SUPPL	2020-09-08
64490	SUPPL	2020-09-04
61954	SUPPL	2020-02-25
61949	SUPPL	2020-02-24
61945	SUPPL	2020-02-24
57250	SUPPL	2019-01-18
57231	SUPPL	2019-01-16
57230	SUPPL	2019-01-16
55923	SUPPL	2018-10-15
55738	SUPPL	2018-10-01
54880	SUPPL	2018-07-13
54824	SUPPL	2018-07-06
50749	SUPPL	2017-12-18
49232	SUPPL	2017-08-04
49231	SUPPL	2017-08-04
49214	SUPPL	2017-08-02
49213	SUPPL	2017-08-02
47052	SUPPL	2017-01-31
47051	SUPPL	2017-01-31
47030	SUPPL	2017-01-27
47029	SUPPL	2017-01-27
9762	SUPPL	2015-07-28
18917	ORIG	2015-04-01
31973	SUPPL	2015-03-11
31974	SUPPL	2014-12-24
44809	ORIG	2014-10-27
22812	ORIG	2014-10-27
9761	ORIG	2014-09-19