Application 212630

Type: ANDA
Sponsor: ENALTEC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212630-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29
A212630-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29
A212630-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29
A212630-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29
A212630-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A212630-001	AB
A212630-002	AB
A212630-003	AB
A212630-004	AB
A212630-005	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 · 170 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
2026-08-18 06:07:40	2026-07	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-11-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212630-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212630-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212630-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212630-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212630-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212630-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212630-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212630-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212630-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212630-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212630-005	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Chartwell RX, LLC	e9d6a9e9-ba25-4c25-9b03-25897a3ac5f3	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212630 application number: ANDA212630 ndc (product): 62135-420 ndc (product): 62135-422 ndc (product): 62135-421 ndc (product): 62135-424 ndc (product): 62135-423
ChlorproMAZINE Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zameer Pharmaceuticals LLC	da3c2935-817d-4331-83c3-ed68ba5d35fd	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212630 application number: ANDA212630 ndc (product): 90096-131 ndc (product): 90096-133 ndc (product): 90096-132 ndc (product): 90096-134 ndc (product): 90096-135

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62135-420	chlorpromazine hydrochloride	chlorpromazine hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-421	chlorpromazine hydrochloride	chlorpromazine hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-422	chlorpromazine hydrochloride	chlorpromazine hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-423	chlorpromazine hydrochloride	chlorpromazine hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-424	chlorpromazine hydrochloride	chlorpromazine hydrochloride	Chartwell RX, LLC	ANDA	Current
90096-131	ChlorproMAZINE Hydrochloride	ChlorproMAZINE Hydrochloride	Zameer Pharmaceuticals LLC	ANDA	Current
90096-132	ChlorproMAZINE Hydrochloride	ChlorproMAZINE Hydrochloride	Zameer Pharmaceuticals LLC	ANDA	Current
90096-133	ChlorproMAZINE Hydrochloride	ChlorproMAZINE Hydrochloride	Zameer Pharmaceuticals LLC	ANDA	Current
90096-134	ChlorproMAZINE Hydrochloride	ChlorproMAZINE Hydrochloride	Zameer Pharmaceuticals LLC	ANDA	Current
90096-135	ChlorproMAZINE Hydrochloride	ChlorproMAZINE Hydrochloride	Zameer Pharmaceuticals LLC	ANDA	Current