Application 213368

Type: ANDA
Sponsor: ZYDUS

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
A213368-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17
A213368-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17
A213368-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17
A213368-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17
A213368-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213368-001	AB
A213368-002	AB
A213368-003	AB
A213368-004	AB
A213368-005	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 · 185 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	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 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	A213368-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213368-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-005	AB	1	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Northstar Rx LLC	2bd42d3a-bf89-4d74-a252-9b914106a570	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213368 application number: ANDA213368 ndc (product): 16714-047 ndc (product): 16714-048 ndc (product): 16714-049 ndc (product): 16714-051 ndc (product): 16714-050
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	fc2bd95d-a7bc-4ab5-bffa-f5059cb8eb63	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213368 application number: ANDA213368 ndc (product): 70710-1131 ndc (product): 70710-1130 ndc (product): 70710-1129 ndc (product): 70710-1133 ndc (product): 70710-1132
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	0ea5e0c6-0062-4be3-96f2-62397da3e77d	2024-06-04		Exact identifier application applno (ANDA): 213368 application number: ANDA213368 ndc (product): 70771-1507 ndc (product): 70771-1510 ndc (product): 70771-1506 ndc (product): 70771-1509 ndc (product): 70771-1508

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7129	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7129	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7130	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7130	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7131	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7131	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7132	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7132	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7133	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7133	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Major Pharmaceuticals	ANDA	Current
16714-047	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Northstar Rx LLC	ANDA	Current
16714-048	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Northstar Rx LLC	ANDA	Current
16714-049	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Northstar Rx LLC	ANDA	Current
16714-050	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Northstar Rx LLC	ANDA	Current
16714-051	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Northstar Rx LLC	ANDA	Current
70518-3034	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3348	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70710-1129	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1129	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1130	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1130	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1131	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1131	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1132	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1132	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1133	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1133	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1506	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1506	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1507	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1507	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1508	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1508	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1509	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1509	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1510	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1510	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Cadila Healthcare Limited	ANDA	Current