Home Applications 205057 Application 205057
Type ANDA
Sponsor ROXANE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAPENTADOL TAPENTADOL TABLET;ORAL 50MG No No 002 TAPENTADOL TAPENTADOL TABLET;ORAL 75MG No No 003 TAPENTADOL TAPENTADOL TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205057-001 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2026-02-10 A205057-002 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2026-02-10 A205057-003 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2026-02-10
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.
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 2026-08-18 06:07:40 2026-07 A205057-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2026-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205057-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2026-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205057-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2026-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205057-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205057-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205057-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-02-10 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205057-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2026-02-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205057-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2026-02-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205057-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2026-02-10 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 · 2 matching rows.