Application 212895
- Type
- NDA
- Sponsor
- CSPC OUYI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CONJUPRI | LEVAMLODIPINE MALEATE | TABLET;ORAL | EQ 1.25MG BASE | Yes | No |
| 002 | CONJUPRI | LEVAMLODIPINE MALEATE | TABLET;ORAL | EQ 2.5MG BASE | Yes | No |
| 003 | CONJUPRI | LEVAMLODIPINE MALEATE | TABLET;ORAL | EQ 5MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212895-001 | CONJUPRI | LEVAMLODIPINE MALEATE | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | |
| N212895-002 | CONJUPRI | LEVAMLODIPINE MALEATE | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | |
| N212895-003 | CONJUPRI | LEVAMLODIPINE MALEATE | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Conjupri | LEVAMLODIPINE | CSPC Ouyi Pharmaceutical Co. Ltd | c3cca66e-348a-43e8-8f96-e995104dae3d | 2024-12-11 | Warnings, Adverse reactions | 212895 NDA212895 24075-0411 24075-0413 |
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 |
|---|---|---|---|---|---|
| 24075-0410 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0410 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0411 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0411 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0411 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0412 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0412 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 24075-0413 | Conjupri | levamlodipine | CSPC Ouyi Pharmaceutical Co. Ltd | NDA | Current |
| 42195-425 | Levamlodipine | levamlodipine | Xspire Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 42195-450 | Levamlodipine | levamlodipine | Xspire Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 66992-425 | Conjupri | levamlodipine | WraSer LLC | NDA | Current |
| 66992-425 | Conjupri | levamlodipine | WraSer LLC | NDA | Current |
| 66992-430 | Conjupri | levamlodipine | WraSer LLC | NDA | Current |
| 69101-512 | Conjupri | levamlodipine maleate | Burke Therapeutics, LLC | NDA | Current |
| 69101-512 | Conjupri | levamlodipine | Burke Therapeutics, LLC | NDA | Current |
| 69101-512 | Conjupri | levamlodipine | Burke Therapeutics, LLC | NDA | Current |
| 69101-525 | Conjupri | levamlodipine maleate | Burke Therapeutics, LLC | NDA | Current |
| 69101-525 | Conjupri | levamlodipine | Burke Therapeutics, LLC | NDA | Current |
| 69101-525 | Conjupri | levamlodipine | Burke Therapeutics, LLC | NDA | Current |
| 69101-550 | Conjupri | levamlodipine maleate | Burke Therapeutics, LLC | NDA | Current |
| 69101-550 | Conjupri | levamlodipine | Burke Therapeutics, LLC | NDA | Current |
| 69101-550 | Conjupri | levamlodipine | Burke Therapeutics, LLC | NDA | Current |