Home Applications 214378 Application 214378
Type ANDA
Sponsor HUMANWELL PURACAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 002 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE || EQ 100MG BASE No No 003 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE 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 A214378-001 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-01-27 A214378-002 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-01-27 A214378-003 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 A214378-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214378-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214378-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214378-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214378-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214378-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214378-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-01-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214378-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-01-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214378-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-01-27 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.
Documents# Document, Submission type, Date table Document Submission type Date 84985 ORIG 2026-02-11