Application 076265
- Type
- ANDA
- Sponsor
- HIKMA INTL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;10MG | No | No |
| 002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;20MG | No | No |
| 003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 25MG;20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | ||
| A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | ||
| A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET / ORAL | 2002-07-08 |
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 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076265-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076265-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076265-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-08 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076265-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076265-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076265-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076265-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076265-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076265-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076265-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076265-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076265-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076265-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076265-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076265-003 | 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 and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 7cc69c16-0dcc-874d-e053-2991aa0a9919 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | NuCare Pharmaceuticals,Inc. | af74c331-7402-408c-e053-2a95a90a1043 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | NuCare Pharmaceuticals,Inc. | b2e8b3bb-0ab5-ffd7-e053-2995a90aa2b6 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | NuCare Pharmaceuticals,Inc. | b4c9abf7-a2c6-7042-e053-2a95a90a7653 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | NuCarePharmaceuticals, Inc. | 4fbf31a1-037b-31a2-e054-00144ff88e88 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Lisinopril and hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals, Inc. | 4925a3ad-63bd-108a-e054-00144ff8d46c | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 6c57bf12-9ad5-3a25-e053-2a91aa0aaf26 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 1a04bf47-07fb-ed32-e063-6294a90a07cc | 2024-06-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 2b66693d-0514-4f41-b405-bd3dd7618e81 | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Bryant Ranch Prepack | 02eb8f54-789e-4148-912b-601d23a7df4a | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | NuCare Pharmaceuticals,Inc. | e0511312-0b07-be89-e053-2995a90ab1e5 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | b20aca90-db82-4fce-95a5-fb2b27c4a6c7 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | A-S Medication Solutions | 3372e46d-8f18-44fd-a9c8-3d8a45d9acdc | 2023-12-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | A-S Medication Solutions | ed019adb-0a18-4aba-9b09-a0c966322d96 | 2023-12-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | A-S Medication Solutions | 9a315f3e-4d70-4308-a842-0e4c647a44b2 | 2023-11-16 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Bryant Ranch Prepack | 5885b1ff-715c-4f90-b43d-bddf94d61acd | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Bryant Ranch Prepack | 1990af86-e9ec-48b8-b354-8456d6d80e0a | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Bryant Ranch Prepack | b7d6f322-6415-4952-a2d4-7f46aca8af9d | 2023-06-22 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Exelan Pharmaceuticals, Inc. | c40b15ec-6083-4778-bca8-3e895e5694e1 | 2023-03-28 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Proficient Rx LP | 84dba61d-cae2-4f21-9a9e-3088f356f838 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
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 |
|---|---|---|---|---|---|
| 0143-1262 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1262 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1262 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1262 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1263 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1263 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1263 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1263 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1264 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1264 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-1264 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1264 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 43353-800 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-975 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2086 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 52959-997 | Lisinopril with Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | H.J. Harkins Company, Inc. | ANDA | Current |
| 66267-751 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-751 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-752 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-752 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67544-276 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 68788-6364 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7389 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0081 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 71335-0284 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0284 | Lisinopril with Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |