Home Applications 218342 Application 218342
Type ANDA
Sponsor UMEDICA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE No No 002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE CAPSULE;ORAL EQ 200MG 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218342-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2026-01-20 A218342-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2026-01-20
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.
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 A218342-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2026-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218342-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2026-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218342-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2026-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218342-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2026-01-20 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218342-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2026-01-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218342-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2026-01-20 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sertraline HCl SERTRALINE HYDROCHLORIDE Biocon Pharma Inc. 623b9672-b41e-4ec9-b2cc-f5bb383c39ba 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218342 application number: ANDA218342