Application 211061

Type: ANDA
Sponsor: APPCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	0.5MG	No	No
002	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	1MG	No	No
003	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	2MG	No	No
004	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	5MG	No	No
005	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	10MG	No	No
006	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211061-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08
A211061-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08
A211061-003	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08
A211061-004	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08
A211061-005	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08
A211061-006	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A211061-001	AB
A211061-002	AB
A211061-003	AB
A211061-004	AB
A211061-005	AB
A211061-006	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 6 · 222 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	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2020-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2020-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2020-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2020-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2020-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2020-01-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 222 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	A211061-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211061-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211061-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211061-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211061-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211061-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211061-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211061-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211061-004	AB	1	`2680178bc6a6…`

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 · 1 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	Exact identifier application applno (ANDA): 211061 application number: ANDA211061 ndc (product): 0832-1530 ndc (product): 0832-1510 ndc (product): 0832-1540 ndc (product): 0832-1550 ndc (product): 0832-1520 ndc (product): 0832-1560

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8355	Haloperidol	Haloperidol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0832-1510	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1510	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1520	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1520	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1530	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1530	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1540	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1540	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1550	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1550	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1560	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1560	Haloperidol	Haloperidol	Upsher-Smith Laboratories, LLC	ANDA	Current
50090-6017	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
70518-2620	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2620	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2620	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2620	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2893	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2893	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current