Application 020517

Type: NDA
Sponsor: ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUPRON DEPOT	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	22.5MG/VIAL	Yes	No
002	LUPRON DEPOT	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	30MG/VIAL	Yes	Yes
003	LUPRON DEPOT	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	45MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020517-001	LUPRON DEPOT	LEUPROLIDE ACETATE	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22
N020517-002	LUPRON DEPOT	LEUPROLIDE ACETATE	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30
N020517-003	LUPRON DEPOT	LEUPROLIDE ACETATE	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020517-003	9617303	2028-03-22	U-4001		2024-10-04
N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020517-002	LUPRON DEPOT	30MG	INJECTABLE / INJECTION	RLD, RS	1997-05-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020517-003	LUPRON DEPOT	45MG	INJECTABLE / INJECTION	RLD, RS	2011-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020517-001	LUPRON DEPOT	22.5MG	INJECTABLE / INJECTION	RLD	1995-12-22	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020517-003	9617303	2028-03-22	U-4001		2024-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020517-003	7429559	2019-01-13		Drug product	2011-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020517-003	8815801	2022-06-28		Drug product	2015-03-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020517-003	8921326	2031-02-05	U-1666	Drug product	2015-03-13	`5aa47cf7b7d7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lupron Depot	LEUPROLIDE ACETATE	AbbVie Inc.	cbc8f94e-7330-4465-05ad-16d64493a5dd	2026-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020517 application number: NDA020517 ndc (product): 0074-3683 ndc (product): 0074-3473 ndc (product): 0074-3346

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3346	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3346	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3346	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3346	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3346	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3473	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3473	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3473	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3473	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3473	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3683	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3683	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3683	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3683	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3683	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83147	SUPPL	2025-08-20
83133	SUPPL	2025-08-19
77927	SUPPL	2024-03-25
77917	SUPPL	2024-03-22
76734	SUPPL	2023-12-05
76730	SUPPL	2023-12-05
70794	SUPPL	2022-04-20
70791	SUPPL	2022-04-19
57914	SUPPL	2019-03-07
57892	SUPPL	2019-03-05
57143	SUPPL	2019-01-09
56833	SUPPL	2018-12-20
12671	SUPPL	2016-06-13
25091	SUPPL	2016-06-08
41409	SUPPL	2015-01-20
41408	SUPPL	2015-01-20
20695	SUPPL	2015-01-20
34747	SUPPL	2014-07-01
25090	SUPPL	2014-07-01
2649	SUPPL	2013-07-12
12670	SUPPL	2013-07-11
2648	SUPPL	2012-07-20
12669	SUPPL	2012-07-19
23581	ORIG	2011-12-20
25087	SUPPL	2011-06-29
2647	SUPPL	2011-06-29
2646	SUPPL	2011-06-29
34746	SUPPL	2011-06-28
34744	SUPPL	2011-06-28
12668	SUPPL	2011-06-28
25089	SUPPL	2011-01-20
12667	SUPPL	2011-01-20
34745	SUPPL	2010-05-07
12666	SUPPL	2010-05-07
12665	SUPPL	2010-05-07
25088	SUPPL	2010-05-04
25086	SUPPL	2010-05-04
2645	SUPPL	2010-05-04
41407	SUPPL	2007-07-09
41406	SUPPL	2007-07-09
20694	SUPPL	2007-07-09
20692	ORIG	2006-04-06
41405	SUPPL	2006-03-30
25085	SUPPL	2005-10-20
2644	SUPPL	2005-10-20
2643	SUPPL	2004-01-14
25084	SUPPL	2003-09-25
20693	SUPPL	1997-05-30