Home Applications 076333 Application 076333
Type ANDA
Sponsor ANI PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 5MG No No 002 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG No No 003 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG No No 004 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076333-001 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 A076333-002 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 A076333-003 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 A076333-004 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11
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 · 172 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 2026-09-14 22:38:34 2026-08 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076333-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076333-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076333-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076333-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 31110 ORIG 2004-02-12