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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076164-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076164-004 | AB | 1 | 2680178bc6a6… |
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 | REMEDYREPACK INC. | 12d6fe7e-b5a2-4d49-9a06-a6150234d061 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Coupler LLC | 560513ef-4d2c-8ca0-e063-6394a90a674a | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | REMEDYREPACK INC. | e17bcc2e-f5ed-4846-95d3-a5479c7fee8d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 5f4c1a62-fb84-8cdc-e053-2a91aa0a671a | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 60760-359 |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 5eff766f-82e2-4cd6-e053-2a91aa0a4782 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 60760-360 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4b6dc0d4-4acd-3606-e054-00144ff8d46c | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | ab561d21-7466-4d8b-8d06-291c1d4d82ff | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | 02c23f9c-f3cf-4366-ae1e-56296f1fedf9 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | f57bd658-05d8-475a-ae74-87d2c7866417 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | bd804d65-742a-4890-ac9d-bee69968387d | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 11a83bbc-9871-4df8-b3f2-7aba5149f3fe | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 50090-2934 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | eddec313-910c-4bf1-9095-2153db53bc6e | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 350c6fc9-9774-4d49-9242-19e96944f83b | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | d18f2117-0d2a-4e0d-8ffb-130ca6900364 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | RedPharm Drug, Inc. | 4f08cfc9-7afc-33aa-e054-00144ff88e88 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | ab2f8ab5-3c87-484a-e053-2995a90a42bb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 51655-335 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | ae2cdf9b-e71e-8315-e053-2995a90a5310 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | dac0c8f1-e3cf-11e6-e053-2a95a90adbcb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | ae2d9df4-29ce-3d07-e053-2995a90ab184 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 51655-411 |
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 |