Application 075504
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 003 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 004 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075504-001 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | ||
| A075504-002 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | ||
| A075504-003 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | ||
| A075504-004 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075504-001 | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2007-08-24 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075504-002 | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-08-24 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075504-003 | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-08-24 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075504-004 | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-08-24 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A075504-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075504-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075504-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075504-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A075504-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075504-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075504-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075504-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075504-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075504-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075504-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075504-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075504-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075504-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075504-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075504-004 | 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 |
|---|---|---|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|---|
| 63629-1241 | Quinapril | Quinapril | Bryant Ranch Prepack | ANDA | Current |