Application 212144

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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 1.

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
A212144-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23
A212144-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23
A212144-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23
A212144-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23
A212144-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212144-001	AB
A212144-002	AB
A212144-003	AB
A212144-004	AB
A212144-005	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
2026-02-19 14:30 UTC	2026-02	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-03-23	`5bbf6a4d5a75…`

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
2026-02-19 14:30 UTC	2026-02	A212144-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212144-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212144-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212144-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212144-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212144-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212144-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212144-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212144-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212144-005	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212144-001	CGT	2021-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212144-002	CGT	2021-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212144-003	CGT	2021-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212144-004	CGT	2021-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212144-005	CGT	2021-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212144-001	CGT	2021-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212144-002	CGT	2021-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212144-003	CGT	2021-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212144-004	CGT	2021-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212144-005	CGT	2021-09-20	`87673890dc5c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	a6065ac5-a111-449b-b51b-8bc2907d1ddb	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212144 application number: ANDA212144 ndc (product): 68462-862 ndc (product): 68462-864 ndc (product): 68462-863 ndc (product): 68462-865 ndc (product): 68462-861

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-861	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-861	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-862	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-862	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-863	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-863	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-864	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-864	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-865	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-865	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-3280	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3435	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67039	ORIG	2021-04-13