Application 209101

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No
002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 100MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209101-001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO		2018-07-03
A209101-002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO		2018-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209101-001	AO
A209101-002	AO

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209101-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209101-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2018-07-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209101-001	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209101-002	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209101-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209101-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209101-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209101-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209101-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209101-002	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209101-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209101-002	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209101-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209101-002	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209101-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209101-002	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209101-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209101-002	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209101-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209101-002	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209101-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209101-002	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209101-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209101-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209101-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209101-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209101-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209101-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209101-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209101-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209101-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209101-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209101-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209101-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209101-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209101-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209101-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209101-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209101-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209101-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209101-001	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209101-002	AO	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	f2bff27f-929f-4f7d-b3eb-084ebc2a885f	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209101 application number: ANDA209101 ndc (product): 70069-031 ndc (product): 70069-030 ndc (product): 70069-381 ndc (product): 70069-382 ndc (product): 70069-383 ndc (product): 70069-384
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	BluePoint Laboratories	f2d14406-2ad4-4c5b-9c24-a026f27b415d	2023-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209101 application number: ANDA209101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LL	ANDA	Current
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LL	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	ANDA	Current
70518-2520	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	ANDA	Current
70518-2520	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	ANDA	Current
70518-2520	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	ANDA	Current
70518-2520	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	ANDA	Current
70518-3170	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	ANDA	Current
70518-3170	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	ANDA	Current