Home Applications 080983 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 1 .
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.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 74a2ff9319b5…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…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 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.