Application 071132

Type: ANDA
Sponsor: CYCLE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL		1987-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071132-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1987-05-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A071132-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071132-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071132-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071132-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A071132-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071132-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071132-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071132-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071132-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071132-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071132-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071132-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071132-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071132-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071132-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071132-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071132-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071132-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071132-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35573-442	HALOPERIDOL	HALOPERIDOL	Burel Pharmaceuticals, Inc.	ANDA	Current
35573-442	HALOPERIDOL	HALOPERIDOL	Burel Pharmaceuticals, LLC	ANDA	Current