Application 075994
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 5MG | No | No |
| 003 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 10MG | No | No |
| 004 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 20MG | No | No |
| 005 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 30MG | No | No |
| 006 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075994-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075994-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075994-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075994-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075994-005 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075994-006 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075994-001 | AB |
| A075994-002 | AB |
| A075994-003 | AB |
| A075994-004 | AB |
| A075994-005 | AB |
| A075994-006 | AB |
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 | 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 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075994-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075994-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075994-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075994-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075994-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075994-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075994-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075994-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075994-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075994-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075994-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075994-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075994-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075994-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075994-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075994-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075994-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075994-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075994-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075994-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075994-004 | AB | 1 | b8a1b40f171c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | 03a497fe-fb09-4b2c-8ee0-2019600192b8 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | dd015c18-1ea6-44e3-9186-8d2f8444d874 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | e4c11545-00da-4675-856a-7e600a2f4bd9 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | cced442b-8047-4489-95d6-0700a66fba34 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | fbd3bde1-ee64-126f-e053-6394a90a9b6d | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | fbfa23c2-dae0-4f45-e053-6394a90a4fef | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 964c7f28-f62e-30b5-e053-2a95a90ab84c | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 9ba3610b-de5c-fa33-e053-2a95a90acbc5 | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Zestril | LISINOPRIL | Upsher-Smith Laboratories, LLC | 838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Quality Care Products LLC | 29e9ac54-f9da-495c-9102-2aac2cc7d88a | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Quality Care Products LLC | babb75f0-bccc-44e8-955a-6873344ccc21 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4f1f76fe-816c-384a-e054-00144ff88e88 | 2024-12-03 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | NCS HealthCare of KY, LLC dba Vangard Labs | 3121a4c6-d5c2-4608-a0be-2d9f4b955d5f | 2024-10-18 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 8f63c3e0-0b3f-4a04-a592-2ce10dfda202 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 06ca101e-4498-4c4e-b455-01915e7ecca0 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 24f532f2-c41e-4d1d-989e-7a56b60fbdd4 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 0bf433cb-bf7d-4b41-9518-400646f9aa2a | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | bebf037f-10f8-4e1f-a512-614f81deb891 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 37aa2542-de44-401b-a6ff-96d2e07914c7 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 33ebf3f2-cd71-4d8b-ac22-1a20a068a13d | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0185-0025 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0101 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0102 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0103 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0104 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0602 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0605 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0610 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0620 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0630 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-0640 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0185-5400 | lisinopril | lisinopril | Eon Labs, Inc. | ANDA | Current |
| 0615-7774 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7775 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7776 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7777 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7778 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7779 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7917 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7918 | lisinopril | lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7934 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-5811 | lisinopril | lisinopril | Major Pharmaceuticals | ANDA | Current |
| 0904-6485 | lisinopril | lisinopril | Major Pharmaceuticals | ANDA | Current |
| 0904-6486 | lisinopril | lisinopril | Major Pharmaceuticals | ANDA | Current |
| 0904-6487 | lisinopril | lisinopril | Major Pharmaceuticals | ANDA | Current |
| 10544-903 | lisinopril | lisinopril | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-904 | lisinopril | lisinopril | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-905 | lisinopril | lisinopril | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-373 | lisinopril | lisinopril | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33358-212 | lisinopril | lisinopril | RxChange Co. | ANDA | Current |
| 33358-213 | lisinopril | lisinopril | RxChange Co. | ANDA | Current |
| 48433-332 | lisinopril | lisinopril | Safecor Health, LLC | ANDA | Current |
| 50090-2952 | lisinopril | lisinopril | A-S Medication Solutions | ANDA | Current |
| 50436-7988 | lisinopril | lisinopril | Unit Dose Services | ANDA | Current |
| 51655-402 | LISINOPRIL | LISINOPRIL | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-408 | LISINOPRIL | LISINOPRIL | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53808-0999 | lisinopril | lisinopril | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-3331 | lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-7639 | lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-7641 | lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-7641 | lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 61919-161 | LISINOPRIL | LISINOPRIL | DIRECT RX | ANDA | Current |
| 61919-161 | LISINOPRIL | LISINOPRIL | DIRECT RX | ANDA | Current |
| 61919-356 | LISINOPRIL | LISINOPRIL | DirectRX | ANDA | Current |
| 61919-942 | LISINOPRIL | LISINOPRIL | DIRECT RX | ANDA | Current |
| 61919-942 | LISINOPRIL | LISINOPRIL | DIRECT RX | ANDA | Current |
| 63187-722 | lisinopril | lisinopril | Proficient Rx LP | ANDA | Current |
| 63187-722 | lisinopril | lisinopril | Proficient Rx LP | ANDA | Current |
| 64725-1020 | lisinopril | lisinopril | TYA Pharmaceuticals | ANDA | Current |
| 64725-5400 | lisinopril | lisinopril | TYA Pharmaceuticals | ANDA | Current |
| 66267-583 | lisinopril | lisinopril | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-583 | lisinopril | lisinopril | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67296-0630 | lisinopril | lisinopril | RedPharm Drug Inc. | ANDA | Current |
| 68001-267 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-267 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-268 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-268 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-269 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-269 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-270 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-270 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-271 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-271 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-272 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68001-272 | lisinopril | lisinopril | BluePoint Laboratories | ANDA | Current |
| 68071-3070 | lisinopril | lisinopril | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-4290 | lisinopril | lisinopril | Carilion Materials Management | ANDA | Current |
| 68788-8914 | lisinopril | lisinopril | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8943 | lisinopril | lisinopril | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9765 | lisinopril | lisinopril | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1268 | lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
| 70518-1268 | lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
| 70882-103 | lisinopril | lisinopril | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
| 70882-104 | Lisinopril | lisinopril | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
| 70882-110 | lisinopril | lisinopril | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31057 | ORIG | 2004-06-08 |