Application 214827

Type: ANDA
Sponsor: MSN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214827-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27
A214827-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27
A214827-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27
A214827-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214827-001	AB
A214827-002	AB
A214827-003	AB
A214827-004	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 4 · 128 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	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	A214827-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214827-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214827-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-004	AB	1	`d06236e962d9…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	American Health Packaging	85ab0b93-c716-4889-87db-9e76e75df7c7	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d3b09b67-e8da-450d-8a52-b3c40605de26	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827 ndc (product): 70518-3584
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	b8137906-946c-455d-87c0-0e130cd9266f	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	2122d619-3f5b-48f6-8f0b-7693199abbdb	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827 ndc (product): 70518-3510
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	c2a38be8-43e6-4a56-9556-fe3dad412b82	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827 ndc (product): 70518-3549
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Coupler LLC	472e9a45-4060-3b2a-e063-6294a90a716a	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Coupler LLC	35a743a1-5354-2c50-e063-6394a90a15f9	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	315ce03f-d9f8-4f3a-9e83-922747430c23	2022-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827 ndc (product): 72205-105 ndc (product): 72205-106 ndc (product): 72205-104 ndc (product): 72205-107

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3510	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3510	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3549	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3584	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
72205-104	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-105	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-106	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-107	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current