Application 071209

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	5MG	No	No
002	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	0.5MG	No	No
003	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	1MG	No	No
004	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A071209-001	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17
A071209-002	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17
A071209-003	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17
A071209-004	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A071209-001	AB
A071209-002	AB
A071209-003	AB

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 4 · 139 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
2026-09-14 22:38:34	2026-08	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071209-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071209-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071209-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071209-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071209-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071209-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071209-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071209-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071209-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071209-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071209-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071209-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071209-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071209-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071209-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071209-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071209-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071209-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071209-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071209-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071209-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071209-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071209-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071209-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071209-001	AB	1	`301d65b070ca…`

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 2 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7212f03f-caa0-43bc-aac5-9d8b3c304897	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	NCS HealthCare of KY, LLC dba Vangard Labs	8743da03-67f1-4cb0-8159-45141cb5466e	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	a3afd19a-c340-4fad-8ddd-d71242515345	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	22598f07-501b-471a-b512-449d95e2301c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	AiPing Pharmaceutical, Inc	bacc68ed-717b-477a-afa4-c45c182c617b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	e07f02d4-2768-4978-97ee-23ac52d0b846	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL LACTATE	REMEDYREPACK INC.	e702b2f0-d464-41c3-977a-d37bb22c0ab0	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol Lactate	HALOPERIDOL	Henry Schein, Inc.	65df5d2d-79aa-41d4-866a-566e520320f7	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	eb69959d-5967-41ac-a222-ff4416869dfc	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	b5a6c54c-fb70-4132-90ae-7d75b5e9c9de	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Novadoz Pharmaceuticals LLC	3a474e06-fb00-40cb-aa3a-6edad43c2c0a	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	1e396020-899d-4f51-b71a-4982c503ca4f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	58fa9328-b1c7-407c-b215-9887db90cb94	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Innogenix, Inc.	2c26af24-5ed3-4eb7-8d29-d6a019320a70	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Creekwood Pharmaceuticals LLC	9763c044-7430-48f7-bf3e-da1c7c683955	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Advagen Pharma Ltd	8bfdc739-51b4-4914-9a60-923e83762307	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	966db55f-3f12-4653-9668-1beff85df0ab	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	5f4d945e-97f0-4afc-88d6-9b55ec238686	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	9353117e-bd01-441a-b35f-fd1352c5df8c	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	457b8b71-8acf-47f1-93e5-1d353e53af10	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1396	Haloperidol	Haloperidol	Sandoz Inc	ANDA	Current
0781-1396	Haloperidol	Haloperidol	Sandoz Inc	ANDA	Current
0904-5925	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
21695-653	Haloperidol	Haloperidol	Rebel Distributors Corp	ANDA	Current
50090-2668	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
50090-3365	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
53808-0263	Haloperidol	Haloperidol	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5414	Haloperidol	Haloperidol	Cardinal Health	ANDA	Current
63187-842	Haloperidol	Haloperidol	Proficient Rx LP	ANDA	Current
63187-842	Haloperidol	Haloperidol	Proficient Rx LP	ANDA	Current
70518-1529	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1529	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current