Home Applications 219482 Application 219482
Type ANDA
Sponsor AJANTA PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE No No 002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE No No 003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE No No 004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219482-001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 A219482-002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 A219482-003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 A219482-004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-02-19 14:30 UTC 2026-02 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 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.