Application 080983

Type: ANDA
Sponsor: FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	SONAZINE	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	30MG/ML	No	No
005	SONAZINE	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	100MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080983-004	SONAZINE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML	CONCENTRATE / ORAL	AA	Approved before 1982
A080983-005	SONAZINE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML	CONCENTRATE / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A080983-004	AA
A080983-005	AA

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080983-004	SONAZINE	30MG/ML	CONCENTRATE / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080983-005	SONAZINE	100MG/ML	CONCENTRATE / ORAL	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080983-004	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080983-005	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080983-004	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080983-005	AA	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080983-004	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080983-005	AA	1	`a50c72e98297…`

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	Saptalis Pharmaceuticals, LLC.	cd8f9e23-d08a-4d96-8fe9-35ab2bc861c8	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080983 application number: ANDA080983

Reported adverse events (FAERS/openFDA)#

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