Application 205241

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
A205241-001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO		2017-05-12
A205241-002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO		2017-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205241-001	AO
A205241-002	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	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205241-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205241-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2017-05-12	`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	A205241-001	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205241-002	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205241-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205241-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205241-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205241-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205241-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205241-002	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205241-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205241-002	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205241-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205241-002	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205241-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205241-002	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205241-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205241-002	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205241-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205241-002	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205241-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205241-002	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205241-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205241-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205241-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205241-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205241-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205241-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205241-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205241-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205241-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205241-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205241-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205241-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205241-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205241-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205241-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205241-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205241-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205241-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205241-001	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205241-002	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	Gland Pharma Limited	1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205241 application number: ANDA205241 ndc (product): 68083-138 ndc (product): 68083-137
haloperidol decanoate	HALOPERIDOL DECANOATE	Sagent Pharmaceuticals	b3167043-585f-482f-b8a7-591bc2721bd3	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205241 application number: ANDA205241 ndc (product): 25021-831 ndc (product): 25021-834 ndc (product): 25021-833

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-831	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-831	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-831	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-833	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-833	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-833	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-834	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-834	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
25021-834	haloperidol decanoate	haloperidol decanoate	Sagent Pharmaceuticals	ANDA	Current
68083-137	Haloperidol Decanoate	Haloperidol Decanoate	Gland Pharma Limited	ANDA	Current
68083-137	Haloperidol Decanoate	Haloperidol Decanoate	Gland Pharma Limited	ANDA	Current
68083-137	Haloperidol Decanoate	Haloperidol Decanoate	Gland Pharma Limited	ANDA	Current
68083-138	Haloperidol Decanoate	Haloperidol Decanoate	Gland Pharma Limited	ANDA	Current
68083-138	Haloperidol Decanoate	Haloperidol Decanoate	Gland Pharma Limited	ANDA	Current
68083-138	Haloperidol Decanoate	Haloperidol Decanoate	Gland Pharma Limited	ANDA	Current
70518-1281	haloperidol decanoate	haloperidol decanoate	REMEDYREPACK INC.	ANDA	Current