Application 203696

Type: NDA
Sponsor: ABBVIE ENDOCRINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	3.75MG/VIAL,N/A;N/A,5MG	Yes	No
002	LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	11.25MG/VIAL,N/A;N/A,5MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203696-001	LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL		RLD	2012-12-14
N203696-002	LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL		RLD	2012-12-14

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 3 · 82 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	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD, RS	2012-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`782e0a99824c…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-1052	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1052	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1052	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1052	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1053	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1053	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1053	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current
0074-1053	Lupaneta Pack	leuprolide acetate and norethindrone acetate	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75034	SUPPL	2023-08-10
75033	SUPPL	2023-08-10
75032	SUPPL	2023-08-10
75029	SUPPL	2023-08-10
75028	SUPPL	2023-08-10
73361	SUPPL	2023-02-02
73353	SUPPL	2023-02-01
19490	SUPPL	2013-11-05
32460	SUPPL	2013-10-31
24446	ORIG	2013-09-09
22932	ORIG	2013-09-09