Home Applications 076803 Application 076803
Type ANDA
Sponsor YAOPHARMA CO LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 002 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No 003 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE No No 004 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 40MG 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 A076803-001 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 A076803-002 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 A076803-003 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 A076803-004 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02
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.
Product history page 1 of 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
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 Quinapril QUINAPRIL Chartwell RX, LLC dbc43dbd-94aa-40e2-a9ea-766110cc8687 2023-11-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076803 application number: ANDA076803