Application 020125
- Type
- NDA
- Sponsor
- PFIZER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 10MG BASE | Yes | No |
| 002 | ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 20MG BASE | Yes | No |
| 003 | ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 25MG;EQ 20MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020125-001 | ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | |
| N020125-002 | ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | |
| N020125-003 | ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 |
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 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020125-002 | ACCURETIC | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020125-003 | ACCURETIC | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020125-001 | ACCURETIC | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-12-28 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020125-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020125-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020125-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020125-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020125-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020125-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020125-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020125-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020125-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020125-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020125-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020125-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020125-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020125-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020125-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020125-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020125-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020125-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020125-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020125-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020125-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020125-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020125-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020125-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020125-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020125-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020125-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020125-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020125-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020125-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020125-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020125-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020125-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020125-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020125-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020125-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020125-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020125-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020125-003 | AB | 1 | ea99ee380514… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020125-001 | AB | 1 | 3a93d1ddd44b… |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0220 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0222 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0223 | ACCURETIC | quinapril hydrochloride and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-3112 | ACCURETIC | quinapril and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-3112 | ACCURETIC | quinapril and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-5212 | ACCURETIC | quinapril and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-5212 | ACCURETIC | quinapril and hydrochlorothiazide | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 59762-0220 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0220 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0220 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0220 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0220 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0222 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0222 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0222 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0222 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0222 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0223 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0223 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0223 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0223 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0223 | quinapril hydrochloride and hydrochlorothiazide | quinapril hydrochloride and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5225 | quinapril and hydrochlorothiazide | quinapril and hydrochlorothiazide | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66322 | SUPPL | 2021-02-23 |
| 66315 | SUPPL | 2021-02-22 |
| 64433 | SUPPL | 2020-08-27 |
| 64353 | SUPPL | 2020-08-21 |
| 62831 | SUPPL | 2020-05-06 |
| 62830 | SUPPL | 2020-05-06 |
| 48205 | SUPPL | 2017-05-02 |
| 48128 | SUPPL | 2017-04-27 |
| 12237 | SUPPL | 2015-09-14 |
| 34286 | SUPPL | 2015-02-06 |
| 2048 | SUPPL | 2015-02-06 |
| 21190 | SUPPL | 2014-05-06 |
| 12236 | SUPPL | 2014-05-06 |
| 34284 | SUPPL | 2014-01-22 |
| 2047 | SUPPL | 2014-01-21 |
| 34285 | SUPPL | 2013-10-31 |
| 21189 | SUPPL | 2013-10-28 |
| 21188 | SUPPL | 2013-09-24 |
| 34283 | SUPPL | 2013-09-23 |
| 34282 | SUPPL | 2012-09-25 |
| 2046 | SUPPL | 2012-09-24 |
| 34281 | SUPPL | 2012-01-23 |
| 2045 | SUPPL | 2012-01-23 |
| 34280 | SUPPL | 2011-10-20 |
| 21187 | SUPPL | 2011-10-18 |
| 2044 | SUPPL | 2011-03-24 |
| 12235 | SUPPL | 2011-03-22 |
| 2043 | SUPPL | 2009-11-12 |
| 12234 | SUPPL | 2009-10-01 |
| 2042 | SUPPL | 2003-11-05 |
| 41148 | ORIG | 2001-05-31 |
| 34279 | ORIG | 1999-12-28 |
| 21186 | ORIG | 1999-12-28 |