Application 219168

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No
002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 100MG BASE/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219168-001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO		2025-05-13
A219168-002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO		2025-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A219168-001	AO
A219168-002	AO

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
2026-02-19 14:30 UTC	2026-02	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219168-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219168-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219168-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219168-002	AO	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-001	AO	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-002	AO	1	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	80d51d2c-30e4-4eef-b184-0cebb30ca429	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	9979e28f-2716-4788-8605-16f6edf158b5	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	15b82169-882b-40ef-bbda-5adc3e7eb930	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	068fc913-779d-44c6-9585-3aa80e751bee	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Caplin Steriles Limited	4f9af14a-38c4-4826-aca0-3501edb854e3	2025-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	f9876b88-3caa-4c08-9a59-9b4a455e101d	2025-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168