Application 078347

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL LACTATE	INJECTABLE;INJECTION	EQ 5MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078347-001	HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078347-001	AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078347-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2009-09-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A078347-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078347-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078347-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078347-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078347-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078347-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078347-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078347-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078347-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078347-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078347-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078347-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078347-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078347-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078347-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078347-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078347-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078347-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078347-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078347-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078347-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078347-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078347-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078347-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078347-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078347-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078347-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078347-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078347-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078347-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078347-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078347-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078347-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078347-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078347-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078347-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078347-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078347-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078347-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078347-001	AP	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	4289f7db-e25d-4578-8adf-f0222ae64aa6	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078347 application number: ANDA078347 ndc (product): 70518-1053
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	7d1a9689-23c8-44ef-a474-8c607e13d794	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078347 application number: ANDA078347 ndc (product): 55154-7076
Haloperidol Lactate	HALOPERIDOL	Henry Schein, Inc.	65df5d2d-79aa-41d4-866a-566e520320f7	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078347 application number: ANDA078347 ndc (product): 0404-9871
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Mylan Institutional LLC	909259a3-7627-4d1e-91d3-3363b3493599	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078347 application number: ANDA078347 ndc (product): 67457-426

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9871	Haloperidol Lactate	Haloperidol	Henry Schein, Inc.	ANDA	Current
0404-9871	Haloperidol Lactate	Haloperidol	Henry Schein, Inc.	ANDA	Current
0404-9871	Haloperidol Lactate	Haloperidol	Henry Schein, Inc.	ANDA	Current
52584-426	Haloperidol Lactate	Haloperidol	General Injectables and Vaccines, Inc.	ANDA	Current
52584-426	Haloperidol Lactate	Haloperidol	General Injectables and Vaccines, Inc.	ANDA	Current
52584-426	Haloperidol Lactate	Haloperidol	General Injectables and Vaccines, Inc.	ANDA	Current
52584-426	Haloperidol Lactate	Haloperidol	General Injectables and Vaccines, Inc.	ANDA	Current
52584-426	Haloperidol Lactate	Haloperidol	General Injectables and Vaccines, Inc.	ANDA	Current
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	ANDA	Current
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health	ANDA	Current
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health	ANDA	Current
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health	ANDA	Current
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health	ANDA	Current
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health	ANDA	Current
67457-426	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Mylan Institutional LLC	ANDA	Current
67457-426	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Mylan Institutional LLC	ANDA	Current
67457-426	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Mylan Institutional LLC	ANDA	Current
70518-1053	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	ANDA	Current
70518-1053	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	ANDA	Current
70518-1053	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	ANDA	Current
70518-1053	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	ANDA	Current
70518-1053	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	ANDA	Current