Application 076164
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 20MG | No | No |
| 002 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 30MG | No | No |
| 003 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 40MG | No | No |
| 004 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 2.5MG | No | No |
| 005 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 5MG | No | No |
| 006 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076164-001 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-002 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-003 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-004 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-005 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-006 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076164-001 | AB |
| A076164-002 | AB |
| A076164-003 | AB |
| A076164-004 | AB |
| A076164-005 | AB |
| A076164-006 | 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 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-004 | LISINOPRIL | 2.5MG | 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 | A076164-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-004 | 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 | Bryant Ranch Prepack | 37aa2542-de44-401b-a6ff-96d2e07914c7 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Solco healthcare U.S., LLC | e299d477-a612-4af4-b6aa-f5addc8a736d | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 43547-354 43547-355 43547-356 |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 1ec55dd0-9ed5-40d2-978e-9fe773f2281a | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 6f7f5697-acb0-ea95-e053-2991aa0ae7c7 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 6314e49c-8715-2f01-e053-2a91aa0ab2a5 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 5786b8d9-3818-66a5-e053-2991aa0a7025 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 51c80515-b26d-5776-e054-00144ff8d46c | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 54dc1e7e-6abd-4f6d-8b41-2b2731d51a65 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 50090-4887 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 3f6bc45e-448e-47f9-9bc4-991b1c503ddf | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 3e4e69f6-b8a6-462d-a7ec-4cd6636512d0 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 06862c94-103d-4b12-8a74-abf52cb42389 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
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 |
|---|---|---|---|---|---|
| 0615-8064 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8064 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8065 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8065 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 42708-096 | LISINOPRIL | Lisinopril | QPharma Inc | ANDA | Current |
| 42708-096 | LISINOPRIL | Lisinopril | QPharma Inc | ANDA | Current |
| 42708-096 | LISINOPRIL | Lisinopril | QPharma Inc | ANDA | Current |
| 42708-142 | LISINOPRIL | Lisinopril | QPharma Inc | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-786 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-800 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-800 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-800 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-800 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-800 | LISINOPRIL | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-297 | LISINOPRIL | Lisinopril | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43547-354 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-354 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-354 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-354 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-355 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-355 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-355 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-355 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-356 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-356 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-356 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-356 | LISINOPRIL | Lisinopril | Solco healthcare U.S., LLC | ANDA | Current |
| 50090-2934 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-2934 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-3763 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-3763 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-3763 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-3763 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-4725 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-4725 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-4887 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50090-4887 | LISINOPRIL | Lisinopril | A-S Medication Solutions | ANDA | Current |
| 50436-0354 | LISINOPRIL | Lisinopril | Unit Dose Services | ANDA | Current |
| 50436-0354 | LISINOPRIL | Lisinopril | Unit Dose Services | ANDA | Current |
| 50436-0354 | LISINOPRIL | Lisinopril | Unit Dose Services | ANDA | Current |
| 50436-0354 | LISINOPRIL | Lisinopril | Unit Dose Services | ANDA | Current |
| 51655-335 | LISINOPRIL | Lisinopril | Northwind Pharmaceuticals | ANDA | Current |
| 51655-335 | LISINOPRIL | Lisinopril | Northwind Pharmaceuticals | ANDA | Current |
| 51655-411 | LISINOPRIL | Lisinopril | Northwind Pharmaceuticals | ANDA | Current |
| 51655-411 | LISINOPRIL | Lisinopril | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1178 | LISINOPRIL | Lisinopril | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1178 | LISINOPRIL | Lisinopril | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1463 | LISINOPRIL | Lisinopril | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1463 | LISINOPRIL | Lisinopril | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-322 | LISINOPRIL | Lisinopril | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-333 | LISINOPRIL | Lisinopril | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-480 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-547 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-547 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-547 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-547 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-558 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-558 | LISINOPRIL | Lisinopril | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-359 | LISINOPRIL | Lisinopril | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-360 | LISINOPRIL | Lisinopril | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-246 | Lisinopril | Lisinopril | Direct_Rx | ANDA | Current |
| 61919-721 | Lisinoril | Lisinopril | Direct_Rx | ANDA | Current |
| 61919-721 | Lisinoril | Lisinopril | Direct_Rx | ANDA | Current |
| 61919-721 | Lisinoril | Lisinopril | Direct_Rx | ANDA | Current |
| 61919-736 | Lisinopril | Lisinopril | Direct_Rx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31091 | ORIG | 2003-04-11 |