Application 212996

Type: ANDA
Sponsor: LANNETT CO INC

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
A212996-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22
A212996-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22
A212996-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22
A212996-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22
A212996-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212996-001	AB
A212996-002	AB
A212996-003	AB
A212996-004	AB
A212996-005	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 · 180 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	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 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	A212996-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212996-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212996-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212996-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212996-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212996-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212996-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212996-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212996-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212996-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212996-005	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	Golden State Medical Supply, Inc.	c212a2a1-323a-8b61-e053-2995a90a5b04	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212996 application number: ANDA212996 ndc (product): 51407-434 ndc (product): 51407-437 ndc (product): 51407-436 ndc (product): 51407-438 ndc (product): 51407-435
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Lannett Company, Inc.	1049538a-c012-41bf-932e-3c85f57f9577	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212996 application number: ANDA212996 ndc (product): 0527-2965 ndc (product): 0527-2964 ndc (product): 0527-2962 ndc (product): 0527-2963 ndc (product): 0527-2961

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2961	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2961	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2962	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2962	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2963	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2963	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2964	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2964	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2965	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2965	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
51407-434	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-434	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-435	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-435	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-436	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-436	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-437	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-437	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-438	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-438	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
70518-3086	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3590	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current