Home Applications 076402 Application 076402
Type ANDA
Sponsor CASI 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 A076402-001 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 A076402-002 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 A076402-003 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 A076402-004 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 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076402-001 BENAZEPRIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076402-002 BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076402-003 BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076402-004 BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 3 of 3 · 56 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Solco healthcare U.S., LLC bb91223e-ffa5-4a3a-b191-fe121250c20c 2024-06-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 99755c59-18b9-ab7b-e053-2a95a90a4155 2024-06-20 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 9987a842-07a5-635e-e053-2995a90afa32 2024-06-20 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 9016634a-1bdd-700d-e053-2995a90a8f27 2024-06-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 800f2a14-98b9-3499-e053-2991aa0a197d 2024-06-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Proficient Rx LP ebdf5144-752d-456f-b46d-19cbba0bc3d7 2024-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE A-S Medication Solutions e0d5362b-f5da-4838-ae91-22f40fcca245 2023-12-03 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Bryant Ranch Prepack b0d3122a-5332-4af6-98d8-520ed70ace62 2023-11-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Bryant Ranch Prepack cd1a7c8f-cc61-4ee4-a259-0b3329cced3e 2023-11-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Proficient Rx LP 313225d7-f947-40b3-96d7-289aad300a4a 2023-08-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Bryant Ranch Prepack 2b02c240-4393-48ed-a385-561ced7b7abf 2023-05-26 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Bryant Ranch Prepack 449e89a3-7bef-44eb-8d73-c77ece611cce 2023-05-08 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE A-S Medication Solutions c5090372-41bf-4677-b198-97fd55a0cb87 2023-02-06 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Proficient Rx LP 9593989f-3129-48ad-9b30-f0b52fb3e91e 2019-10-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Proficient Rx LP 92a26516-3d84-4d7a-a770-523926507887 2019-10-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE Amneal Pharmaceuticals LLC a216253b-27cb-42ef-b5a8-67fb05aafb88 2019-02-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Benazepril Hydrochloride generic name: BENAZEPRIL HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0053 Benazepril Hydrochloride Benazepril Hydrochloride Eon Labs, Inc. ANDA Current 0185-0505 Benazepril Hydrochloride Benazepril Hydrochloride Eon Labs, Inc. ANDA Current 0185-0820 Benazepril Hydrochloride Benazepril Hydrochloride Eon Labs, Inc. ANDA Current 21695-326 Benazepril Hydrochloride Benazepril Hydrochloride Rebel Distributors Corp. ANDA Current 21695-327 Benazepril Hydrochloride Benazepril Hydrochloride Rebel Distributors Corp. ANDA Current 21695-612 Benazepril Hydrochloride Benazepril Hydrochloride Rebel Distributors Corp. ANDA Current 21695-877 Benazepril Hydrochloride Benazepril Hydrochloride Rebel Distributors Corp. ANDA Current 60429-158 Benazepril Hydrochloride Benazepril Hydrochloride Golden State Medical Supply, Inc. ANDA Current 60429-158 Benazepril Hydrochloride Benazepril Hydrochloride Golden State Medical Supply, Inc. ANDA Current 60429-159 Benazepril Hydrochloride Benazepril Hydrochloride Golden State Medical Supply, Inc. ANDA Current 60429-159 Benazepril Hydrochloride Benazepril Hydrochloride Golden State Medical Supply, Inc. ANDA Current 60429-160 Benazepril Hydrochloride Benazepril Hydrochloride Golden State Medical Supply, Inc. ANDA Current 60429-160 Benazepril Hydrochloride Benazepril Hydrochloride Golden State Medical Supply, Inc. ANDA Current 68788-6361 Benazepril Hydrochloride Benazepril Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 68788-9946 Benazepril Hydrochloride Benazepril Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9947 Benazepril Hydrochloride Benazepril Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31118 ORIG 2004-02-27