Application 075999
- Type
- ANDA
- Sponsor
- INVATECH
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 |
|---|---|---|---|---|---|---|---|
| A075999-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | ||
| A075999-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | ||
| A075999-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | ||
| A075999-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | ||
| A075999-005 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | ||
| A075999-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075999-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075999-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075999-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075999-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075999-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075999-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075999-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075999-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075999-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075999-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075999-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075999-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075999-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075999-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075999-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075999-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 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. | c621c33b-cb67-4ea6-b2bd-96c20a244ea4 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4b6dc0d4-4acd-3606-e054-00144ff8d46c | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Coupler LLC | 538429b8-4f10-e825-e063-6294a90a5905 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | ab561d21-7466-4d8b-8d06-291c1d4d82ff | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | 7e297133-669e-4780-a966-c777624e5427 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | affd3e43-077e-42e5-a865-c961624bfe93 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | 02c23f9c-f3cf-4366-ae1e-56296f1fedf9 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals, Inc. | 74415f95-74c9-4329-a6af-a0f165bf7887 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Cardinal Health 107, LLC | 1d0caa63-9ea2-4a97-a23b-900a7c514bc6 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Coupler LLC | 518a63e3-8ca1-bbd1-e063-6294a90aa524 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Coupler LLC | 509a46cf-7a89-b6c0-e063-6394a90a7509 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 08b0555e-41d2-44c3-b27b-ad5d701378dc | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 59fd2167-4da4-9143-83bd-3b6aa5051511 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | f57bd658-05d8-475a-ae74-87d2c7866417 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | bd804d65-742a-4890-ac9d-bee69968387d | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Legacy Pharmaceutical Packaging, LLC | f5db9549-e179-3db6-e053-2995a90a1544 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 11a83bbc-9871-4df8-b3f2-7aba5149f3fe | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | eddec313-910c-4bf1-9095-2153db53bc6e | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 350c6fc9-9774-4d49-9242-19e96944f83b | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8846 | ORIG | 2003-04-16 |