Application 020263

Type: NDA
Sponsor: ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	7.5MG/VIAL	Yes	Yes
003	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	3.75MG/VIAL,7.5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	7.5MG/VIAL,7.5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	11.25MG/VIAL	Yes	Yes
006	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	15MG/VIAL	Yes	Yes
007	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	11.25MG/VIAL	Yes	Yes
008	LUPRON DEPOT-PED	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	30MG/VIAL	Yes	Yes
009	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	POWDER;INTRAMUSCULAR	45MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020263-002	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16
N020263-003	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16
N020263-004	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16
N020263-005	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21
N020263-006	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21
N020263-007	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15
N020263-008	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15
N020263-009	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14

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
N020263-009	9617303	2028-03-22	U-3611		2023-05-12
N020263-009	8921326	2031-02-05		Drug product	2023-05-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N020263-009	NS	2026-04-14

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 8 · 309 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	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 44 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	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`a67488948f0b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020263-009	NS	2026-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	NS	2026-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020263-009	NS	2026-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	NS	2026-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	NS	2026-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020263-009	NS	2026-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020263-009	NS	2026-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020263-009	NS	2026-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020263-009	NS	2026-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020263-009	NS	2026-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020263-009	NS	2026-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020263-009	NS	2026-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020263-009	NS	2026-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020263-009	NS	2026-04-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020263-009	NS	2026-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020263-009	NS	2026-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020263-009	NS	2026-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020263-009	NS	2026-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020263-009	NS	2026-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020263-009	NS	2026-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020263-009	NS	2026-04-14	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020263-009	NS	2026-04-14	`a50c72e98297…`

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-PED	LEUPROLIDE ACETATE	AbbVie Inc.	e99f47d2-da10-3127-ecb3-e5d942ae6e81	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020263 application number: NDA020263 ndc (product): 0074-3779 ndc (product): 0074-2440 ndc (product): 0074-2282 ndc (product): 0074-2108 ndc (product): 0074-9694

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2108	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2282	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-2440	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3779	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-9694	Lupron Depot-PED	leuprolide acetate	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84181	SUPPL	2025-11-18
84174	SUPPL	2025-11-17
84173	SUPPL	2025-11-17
83457	SUPPL	2025-09-25
83424	SUPPL	2025-09-24
82447	SUPPL	2025-06-03
82331	SUPPL	2025-05-27
76735	SUPPL	2023-12-15
76732	SUPPL	2023-12-05
74008	SUPPL	2023-04-17
74001	SUPPL	2023-04-17
70827	SUPPL	2022-04-27
70826	SUPPL	2022-04-27
70808	SUPPL	2022-04-26
69307	SUPPL	2021-11-15
66768	SUPPL	2021-03-12
66767	SUPPL	2021-03-12
66766	SUPPL	2021-03-12
66765	SUPPL	2021-03-12
66763	SUPPL	2021-03-12
66762	SUPPL	2021-03-12
62615	SUPPL	2020-04-21
62614	SUPPL	2020-04-21
62479	SUPPL	2020-04-08
53722	SUPPL	2018-04-18
48494	SUPPL	2017-05-23
48476	SUPPL	2017-05-22
48475	SUPPL	2017-05-22
34452	SUPPL	2013-05-21
2268	SUPPL	2013-05-16
44052	ORIG	2011-12-20
34451	SUPPL	2011-10-12
24693	SUPPL	2011-10-12
24692	SUPPL	2011-08-17
34450	SUPPL	2011-08-15
24691	SUPPL	2010-09-02
34449	SUPPL	2010-08-30
24690	SUPPL	2009-06-30
12394	SUPPL	2009-06-29
2267	SUPPL	2008-08-05
41253	SUPPL	2007-07-09
41252	SUPPL	2007-07-09
41251	SUPPL	2007-07-09
20576	SUPPL	2007-07-09
34448	SUPPL	2006-02-22
2266	SUPPL	2006-02-22
24689	SUPPL	2005-11-18
12393	SUPPL	2005-11-17
12392	SUPPL	2004-04-05
24688	SUPPL	2004-03-10
24687	SUPPL	2003-12-24
24686	SUPPL	2003-10-31
2265	SUPPL	2002-09-24