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 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.
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 3 of 3 · 86 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 2022-09-29 23:25 UTC 2022-09 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A080983-004 SONAZINE 30MG/ML CONCENTRATE / ORAL AA Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A080983-005 SONAZINE 100MG/ML CONCENTRATE / ORAL AA Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.