Application 076071
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A076071-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | ||
| A076071-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | ||
| A076071-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | ||
| A076071-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | ||
| A076071-005 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | ||
| A076071-006 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076071-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076071-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076071-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076071-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076071-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076071-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076071-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076071-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076071-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076071-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076071-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076071-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076071-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076071-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076071-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076071-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A076071-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076071-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076071-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076071-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076071-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076071-006 | AB | 1 | ea99ee380514… |
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. | 463308ef-16cb-41d8-8d29-6aae2c5a7b0f | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | REMEDYREPACK INC. | 34bb4602-ccff-4939-91b9-26a63bfd40f7 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Aurobindo Pharma Limited | 0e6364a4-6d66-4151-8197-d45e2a762895 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 6051cc96-86e0-bd0b-e053-2a91aa0a5dcf | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | REMEDYREPACK INC. | a33d860a-1e17-45b7-aede-51ab3223bebd | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | REMEDYREPACK INC. | 42f49299-7ae5-4d30-86eb-66b739c0e95d | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | REMEDYREPACK INC. | 12d6fe7e-b5a2-4d49-9a06-a6150234d061 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Coupler LLC | 560513ef-4d2c-8ca0-e063-6394a90a674a | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | A-S Medication Solutions | 88b5a2c0-6ad2-48e7-9ffe-715d9159f389 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | A-S Medication Solutions | 34953f77-bae1-41fe-af11-3ea0b3ceaa11 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | REMEDYREPACK INC. | 3451292b-7867-4dc2-afaa-da66b4016017 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | REMEDYREPACK INC. | d32923fe-a323-43c6-af46-bcba7274b0bf | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | REMEDYREPACK INC. | e17bcc2e-f5ed-4846-95d3-a5479c7fee8d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 6062fd98-7663-f4b5-e053-2a91aa0acbc3 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 5f4c1a62-fb84-8cdc-e053-2a91aa0a671a | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Unit Dose Solutions, Inc. | 551665a0-9a92-55df-e063-6394a90a1e2e | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Unit Dose Solutions, Inc. | 55189717-f5db-9c63-e063-6294a90a6bc9 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Unit Dose Solutions, Inc. | 55191baa-f812-2e71-e063-6294a90a8edf | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 5eff766f-82e2-4cd6-e053-2a91aa0a4782 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | c621c33b-cb67-4ea6-b2bd-96c20a244ea4 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-2072 | Lisinopril | lisinopril | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2073 | Lisinopril | lisinopril | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2074 | Lisinopril | lisinopril | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2075 | Lisinopril | lisinopril | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2076 | Lisinopril | lisinopril | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2077 | Lisinopril | lisinopril | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43353-071 | Lisinopril | lisinopril | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-121 | Lisinopril | lisinopril | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-168 | Lisinopril | lisinopril | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-169 | Lisinopril | lisinopril | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-179 | Lisinopril | lisinopril | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-3388 | Lisinopril | lisinopril | A-S Medication Solutions | ANDA | Current |
| 51079-981 | Lisinopril | lisinopril | Mylan Institutional Inc. | ANDA | Current |
| 51079-982 | Lisinopril | lisinopril | Mylan Institutional Inc. | ANDA | Current |
| 51079-983 | Lisinopril | lisinopril | Mylan Institutional Inc. | ANDA | Current |
| 53808-0104 | Lisinopril | lisinopril | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0702 | Lisinopril | lisinopril | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-5051 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5051 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5052 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5052 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5053 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5053 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5082 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 55154-5082 | Lisinopril | lisinopril | Cardinal Health | ANDA | Current |
| 60429-206 | Lisinopril | lisinopril | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-207 | Lisinopril | lisinopril | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-208 | Lisinopril | lisinopril | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-209 | Lisinopril | lisinopril | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-211 | Lisinopril | lisinopril | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-212 | Lisinopril | lisinopril | Golden State Medical Supply Inc. | ANDA | Current |
| 70518-0402 | Lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
| 70518-0575 | Lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
| 70518-0575 | Lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
| 70518-0726 | Lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
| 70518-0726 | Lisinopril | lisinopril | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8861 | ORIG | 2004-06-24 |