Application 084112

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084112-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084112-001	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A084112-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084112-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084112-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084112-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084112-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084112-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084112-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084112-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084112-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084112-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084112-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084112-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084112-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084112-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084112-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084112-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084112-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084112-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084112-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084112-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084112-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084112-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084112-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084112-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084112-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084112-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084112-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084112-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084112-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084112-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084112-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084112-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084112-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084112-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084112-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084112-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084112-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084112-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084112-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084112-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084112-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084112-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084112-001	AB	1	`f41ea6bd6efb…`

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	REMEDYREPACK INC.	a2ca3aa1-9e3b-4eca-af26-165562cee7bc	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084112 application number: ANDA084112
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5ae79c1e-f523-4358-9f8b-7382a03d59bc	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084112 application number: ANDA084112 ndc (product): 0832-6018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7737	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0781-5914	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5914	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5914	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5914	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5914	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Sandoz Inc	ANDA	Current
0832-0301	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0832-0301	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0832-0301	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0832-6018	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
50090-2791	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5965	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5965	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	A-S Medication Solutions	ANDA	Current
51079-519	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-519	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
64725-5914	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	TYA Pharmaceuticals	ANDA	Current
68151-2478	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	Carilion Materials Management	ANDA	Current
70518-1608	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1608	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1608	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1608	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1995	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1995	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1995	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current