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 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
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	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 5 · 192 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	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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 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	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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-004	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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 ndc (product): 55154-3566
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 ndc (product): 0904-6782 ndc (product): 0904-6733 ndc (product): 0904-6661
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 ndc (product): 70518-1182
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 ndc (product): 68084-250 ndc (product): 68084-249
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 ndc (product): 60687-161
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 ndc (product): 65841-626 ndc (product): 65841-627 ndc (product): 65841-628
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 ndc (product): 68382-079 ndc (product): 68382-080 ndc (product): 68382-081

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 91 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6661	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6661	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6661	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6661	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6661	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6733	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6733	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6733	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6782	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6782	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6782	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
0904-6782	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
50090-3376	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
50090-4365	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
50090-4365	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
50090-4365	Haloperidol	Haloperidol	A-S Medication Solutions	ANDA	Current
50268-391	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50268-392	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50268-392	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50268-392	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50268-392	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50268-393	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50268-393	Haloperidol	Haloperidol	AvPAK	ANDA	Current
50436-0233	Haloperidol	Haloperidol	Unit Dose Services	ANDA	Current
55154-3566	Haloperidol	Haloperidol	Cardinal Health 107, LLC	ANDA	Current
55154-3566	Haloperidol	Haloperidol	Cardinal Health	ANDA	Current
58118-1079	Haloperidol	Haloperidol	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-1079	Haloperidol	Haloperidol	Clinical Solutions Wholesale, LLC	ANDA	Current
60687-161	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
60687-161	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
60687-161	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
60687-161	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
61919-133	HALOPERIDOL	HALOPERIDOL	DIRECT RX	ANDA	Current
61919-133	HALOPERIDOL	HALOPERIDOL	DIRECT RX	ANDA	Current
64725-0080	Haloperidol	Haloperidol	TYA Pharmaceuticals	ANDA	Current
65841-626	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-626	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-626	Haloperidol	Haloperidol	Zydus Lifesciences Limited	ANDA	Current
65841-626	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-627	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-627	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-627	Haloperidol	Haloperidol	Zydus Lifesciences Limited	ANDA	Current
65841-627	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-628	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-628	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
65841-628	Haloperidol	Haloperidol	Zydus Lifesciences Limited	ANDA	Current
65841-628	Haloperidol	Haloperidol	Cadila Healthcare Limited	ANDA	Current
67046-329	Haloperidol	Haloperidol	Contract Pharmacy Services-PA	ANDA	Current
68084-249	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-249	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-249	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-249	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-250	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-250	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-250	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68084-250	Haloperidol	Haloperidol	American Health Packaging	ANDA	Current
68382-079	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-079	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-079	Haloperidol	Haloperidol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-079	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-080	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-080	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-080	Haloperidol	Haloperidol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-080	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-081	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-081	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-081	Haloperidol	Haloperidol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-081	Haloperidol	Haloperidol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-0831	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-0831	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-0831	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-0831	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-0831	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-0831	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1182	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1182	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1182	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1182	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1182	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-1269	Haloperidol	Haloperidol	REMEDYREPACK INC.	ANDA	Current

Documents#

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