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 1.

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 · 131 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
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071209-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071209-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071209-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071209-004	HALOPERIDOL	2MG	TABLET / ORAL		1986-11-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071209-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071209-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071209-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071209-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071209-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071209-001	AB	1	`8072bd15b7f6…`

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 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Upsher-Smith Laboratories, LLC	afb3ac3e-7459-42d3-b5ca-e0d6d27ced73	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	5827f1d4-ff98-03ba-e063-6394a90a4630	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	051f3c99-7d16-4185-a857-c90440e1b1c5	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	746f3ab9-9e6e-4ce8-9384-0c7a57de8007	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Unit Dose Solutions, Inc.	54ee5fa9-e346-a1d0-e063-6294a90aef83	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	e2eed126-cb82-42b1-9b48-9cbeb6873b50	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Safecor Health, LLC	9be08519-b3b5-4b9d-ae4c-bb7e68f19ede	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	50b0ea2f-0a54-7b49-e063-6394a90abcc4	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	26aa869a-25e8-0dd5-e063-6394a90a0aba	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Coupler LLC	509e5424-1323-c841-e063-6294a90a2714	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	861c7b75-572c-48c2-adf9-1ca3fc3db19b	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
Haloperidol	HALOPERIDOL	PD-Rx Pharmaceuticals, Inc.	533b0b4c-cbd6-4ec0-a333-8b04b5b43a1d	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	57d77858-758c-41ce-a47c-ca42c4e88859	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	f6f6f2ed-33a5-4139-b2f1-ce446814e597	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7666e56f-9eef-4343-8a76-60613c4ca57f	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	f6fb9e4c-630b-4f82-8223-f154dd6c17a2	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	42549018-8f15-40b4-ac0a-8b06a2178e46	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL
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

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