Application 019885
- Type
- NDA
- Sponsor
- PFIZER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | Yes | No |
| 002 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | Yes | No |
| 003 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | Yes | No |
| 004 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019885-001 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | |
| N019885-002 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | |
| N019885-003 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | |
| N019885-004 | ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 |
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| 2026-08 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019885-001 | ACCUPRIL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019885-002 | ACCUPRIL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019885-003 | ACCUPRIL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019885-004 | ACCUPRIL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-11-19 | 5bbf6a4d5a75… |
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 | N019885-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019885-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019885-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019885-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019885-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019885-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019885-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019885-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019885-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019885-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019885-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019885-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019885-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019885-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019885-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019885-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019885-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N019885-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N019885-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N019885-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019885-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N019885-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N019885-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N019885-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019885-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019885-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019885-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019885-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N019885-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019885-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019885-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019885-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N019885-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019885-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019885-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019885-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019885-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019885-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019885-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019885-004 | AB | 1 | c0c555d07b60… |
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 | QUINAPRIL HYDROCHLORIDE | Bryant Ranch Prepack | a62d0ed3-8fcc-45fb-9246-b57b08a11f60 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | QUINAPRIL HYDROCHLORIDE |
| Quinapril | QUINAPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 93e6e668-5306-4f26-81d8-cbc3a7a5e787 | 2024-05-15 | Boxed warning, Warnings, Adverse reactions | QUINAPRIL HYDROCHLORIDE |
| Quinapril | QUINAPRIL HYDROCHLORIDE | Proficient Rx LP | 42e4f9dd-6032-4257-bd0f-8e9b71027f03 | 2020-03-01 | Boxed warning, Warnings, Adverse reactions | QUINAPRIL HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0527 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0530 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0532 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0535 | Accupril | quinapril hydrochloride | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 68151-1020 | Quinapril Hydrochloride | quinapril hydrochloride | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
| 68151-1021 | Quinapril Hydrochloride | quinapril hydrochloride | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
| 68151-1022 | Quinapril Hydrochloride | quinapril hydrochloride | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83827 | SUPPL | 2025-10-20 |
| 63153 | SUPPL | 2020-05-20 |
| 48212 | SUPPL | 2017-05-02 |
| 48134 | SUPPL | 2017-04-27 |
| 47216 | SUPPL | 2017-02-15 |
| 47194 | SUPPL | 2017-02-14 |
| 11812 | SUPPL | 2015-09-14 |
| 1760 | SUPPL | 2015-09-14 |
| 34065 | SUPPL | 2014-05-06 |
| 19791 | SUPPL | 2014-05-06 |
| 11811 | SUPPL | 2013-10-31 |
| 1759 | SUPPL | 2013-10-28 |
| 1758 | SUPPL | 2013-09-24 |
| 11810 | SUPPL | 2013-09-23 |
| 34064 | SUPPL | 2013-04-16 |
| 1757 | SUPPL | 2013-04-11 |
| 11809 | SUPPL | 2012-09-25 |
| 34063 | SUPPL | 2012-01-23 |
| 1756 | SUPPL | 2012-01-23 |
| 11808 | SUPPL | 2011-10-20 |
| 1755 | SUPPL | 2011-10-18 |
| 1754 | SUPPL | 2009-11-12 |
| 11807 | SUPPL | 2009-10-01 |
| 44038 | ORIG | 2006-06-09 |
| 1753 | SUPPL | 2003-11-05 |
| 19790 | SUPPL | 2003-07-30 |
| 1752 | SUPPL | 2001-04-17 |