Application 077580

Type: ANDA
Sponsor: ZYDUS PHARMS USA

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	1MG	No	No
003	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	5MG	No	No
004	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	10MG	No	No
005	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	20MG	No	No
006	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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077580-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17
A077580-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17
A077580-003	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29
A077580-004	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29
A077580-005	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29
A077580-006	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	2023-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077580-001	AB
A077580-002	AB
A077580-003	AB
A077580-004	AB
A077580-005	AB
A077580-006	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 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	2023-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	2023-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 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	A077580-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077580-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077580-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077580-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-004	AB	1	`b8a1b40f171c…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Coupler LLC	5827f1d4-ff98-03ba-e063-6394a90a4630	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	746f3ab9-9e6e-4ce8-9384-0c7a57de8007	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580 ndc (product): 70518-1599
Haloperidol	HALOPERIDOL	Unit Dose Solutions, Inc.	54ee5fa9-e346-a1d0-e063-6294a90aef83	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Safecor Health, LLC	9be08519-b3b5-4b9d-ae4c-bb7e68f19ede	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Coupler LLC	26aa869a-25e8-0dd5-e063-6394a90a0aba	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Coupler LLC	509e5424-1323-c841-e063-6294a90a2714	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	e07f02d4-2768-4978-97ee-23ac52d0b846	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	1e396020-899d-4f51-b71a-4982c503ca4f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	58fa9328-b1c7-407c-b215-9887db90cb94	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580 ndc (product): 70518-1269
Haloperidol	HALOPERIDOL	American Health Packaging	0ac0cc44-3924-447d-9051-f84c44312380	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	American Health Packaging	d62617da-c8ad-45da-8915-c59edc5558a5	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Coupler LLC	315899f3-d510-10b0-e063-6294a90a2f3e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Zydus Lifesciences Limited	509d0eb2-b930-4836-9669-dbebf0ac4076	2024-11-30		Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Zydus Pharmaceuticals USA Inc.	54502f78-7244-454a-9171-4e73127f1456	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580

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 2 of 2 · 91 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1269	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1269	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1269	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1269	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1269	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1599	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1599	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1599	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1599	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1599	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2359	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44619	ORIG	2007-12-03