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 4 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Zydus Lifesciences Limited	509d0eb2-b930-4836-9669-dbebf0ac4076	2024-11-30		Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Lifestar Pharma LLC	00bb61c8-db35-4c04-9ef7-47d447d2496b	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Aurobindo Pharma Limited	bf21633e-f37b-4017-a143-538eb005de2d	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Zydus Pharmaceuticals USA Inc.	54502f78-7244-454a-9171-4e73127f1456	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Lannett Company, Inc.	3e44fed0-6132-4881-a9cd-af6156c7af9c	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Marlex Pharmaceuticals, Inc.	e7a61604-741f-2d3b-e053-2995a90a62fc	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	d9d0e530-02cd-4631-b3c8-cf6de521fd5b	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	df340d75-7387-4084-9d76-167283ee7462	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	d896823a-fb08-4777-a1f1-cef85fc8d96c	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	f1c56d0d-87d3-40ef-9578-0d99fbae12fe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	88031df0-90bd-4444-9503-1b4612e3856b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	b9e8f5f2-6d59-4a2c-8ccf-88bb58753f60	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	a8e9d675-135c-4b5d-91d0-1ef0d295535c	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	f20769bc-98a3-419a-ba36-2e9737050cd9	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	33dca652-c60c-44e0-9303-ea55a431fdcd	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	c3b35c6c-e339-439a-b75f-dd645e08a959	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	1171bd60-7105-4b70-a24c-f2bc8c52a8c0	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	a79c12f2-cf98-4337-8b6a-7b9ef2afa9d5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL LACTATE	Hikma Pharmaceuticals USA Inc.	ec7a3560-71c3-43f5-bc6c-d51eadfd2aa1	2022-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Amici Pharmaceuticals, LLC	9a9e20dd-646a-4fe9-a345-1b5bda8e7775	2022-05-02	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