Application 076374
- Type
- ANDA
- Sponsor
- LUPIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUINARETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 10MG BASE | No | No |
| 002 | QUINARETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 20MG BASE | No | No |
| 003 | QUINARETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 25MG;EQ 20MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | |
| A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | |
| A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076374-001 | AB |
| A076374-002 | AB |
| A076374-003 | 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 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | 2004-03-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | 2004-03-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | 2004-03-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | 2004-03-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | 2004-03-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | 2004-03-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | 2004-03-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | 2004-03-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | 2004-03-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | 2004-03-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076374-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076374-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076374-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076374-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076374-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076374-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076374-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076374-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076374-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076374-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076374-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076374-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076374-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076374-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076374-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076374-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076374-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076374-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076374-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076374-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076374-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076374-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076374-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076374-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076374-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076374-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076374-003 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076374-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076374-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076374-003 | AB | 1 | d8e5a09893c0… |
| 2022-04-08 23:34 UTC | 2022-04 | A076374-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076374-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076374-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076374-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076374-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076374-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076374-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076374-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076374-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076374-001 | AB | 1 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Quinapril HCL and Hydrochlorothiazide | QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals,Inc. | 383ecaa6-29c8-4280-a442-c47f101d7c88 | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 076374 ANDA076374 43386-710 43386-711 43386-712 |
| Quinapril and Hydrochlorothiazide | QUINAPRIL AND HYDROCHLOROTHIAZIDE | Chartwell RX, LLC | 2eae533f-d0af-47e8-a1f2-94bc8cc89b5a | 2023-12-11 | Boxed warning, Warnings, Adverse reactions | 076374 ANDA076374 |
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 |
|---|---|---|---|---|---|
| 43386-710 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCl and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-710 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCl and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-711 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-711 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-712 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-712 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31112 | ORIG | 2004-04-07 |