Application 204849

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL LACTATE	INJECTABLE;INJECTION	EQ 5MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204849-001	HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION			2017-09-06

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A204849-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204849-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-09-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204849-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204849-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-09-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204849-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204849-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204849-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204849-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204849-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204849-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204849-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204849-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204849-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204849-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204849-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204849-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204849-001	AP	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204849-001	AP	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 1 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	a0751f2e-05ab-4ba9-9bae-7b791bf1a621	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	addb5b30-d1f8-47dd-ba4c-94d0b01ae17c	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Upsher-Smith Laboratories, LLC	afb3ac3e-7459-42d3-b5ca-e0d6d27ced73	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	5827f1d4-ff98-03ba-e063-6394a90a4630	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	051f3c99-7d16-4185-a857-c90440e1b1c5	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	4289f7db-e25d-4578-8adf-f0222ae64aa6	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	746f3ab9-9e6e-4ce8-9384-0c7a57de8007	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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
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 generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	Safecor Health, LLC	9be08519-b3b5-4b9d-ae4c-bb7e68f19ede	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	7d1a9689-23c8-44ef-a474-8c607e13d794	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	50b0ea2f-0a54-7b49-e063-6394a90abcc4	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	26aa869a-25e8-0dd5-e063-6394a90a0aba	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	509e5424-1323-c841-e063-6294a90a2714	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	861c7b75-572c-48c2-adf9-1ca3fc3db19b	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	57d77858-758c-41ce-a47c-ca42c4e88859	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7666e56f-9eef-4343-8a76-60613c4ca57f	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-110	Haloperidol	Haloperidol Lactate	Akorn	ANDA	Current
17478-110	Haloperidol	Haloperidol Lactate	Akorn, Inc.	ANDA	Current
17478-110	Haloperidol	Haloperidol Lactate	Akorn, Inc.	ANDA	Current
17478-110	Haloperidol	Haloperidol Lactate	Akorn, Inc.	ANDA	Current
17478-110	Haloperidol	Haloperidol Lactate	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49701	ORIG	2017-09-08