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 3 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	ea01b32e-5abe-455d-8813-cef101fa53f1	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	2cffe2ad-3dad-479e-a91a-b41c3dd05ce1	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	8ca14b79-6671-4e44-aa34-6564a92aa197	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	40187e83-1144-db0e-e063-6394a90a42df	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Mylan Institutional Inc.	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	2025-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	38f59751-4741-f588-e063-6294a90a6528	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Method Pharmaceuticals, LLC	87f8773b-bf89-4f7e-bff4-8cad117d5776	2025-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	490efba9-70f1-46b8-9d62-2f96163e25df	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	American Health Packaging	0ac0cc44-3924-447d-9051-f84c44312380	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	American Health Packaging	d62617da-c8ad-45da-8915-c59edc5558a5	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	325d169d-310d-4ada-e063-6294a90afbdd	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	315899f3-d510-10b0-e063-6294a90a2f3e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	American Health Packaging	862d9bcd-aaaf-4b10-9013-f696f4cf9581	2025-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	2ccbc964-a95c-d820-e063-6394a90a4307	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	2ccc2e26-de98-af81-e063-6394a90a040b	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	8a1014d0-d917-40b7-bddd-9ac97df91ef4	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	PAI Holdings, LLC dba PAI Pharma	b488c106-f1ee-4b7b-8516-01162fb929f7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Mylan Pharmaceuticals Inc.	c559b0b0-4087-d12a-e718-c18ccb6811e6	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	e8977803-08a2-4ad0-87d5-63d81c98a536	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL LACTATE	Hikma Pharmaceuticals USA Inc.	8397a841-f240-4767-9dcd-781e6d3f7c7f	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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