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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212895-003 | CONJUPRI | EQ 5MG BASE | TABLET / ORAL | RLD, RS | 2019-12-19 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212895-001 | CONJUPRI | EQ 1.25MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212895-002 | CONJUPRI | EQ 2.5MG BASE | TABLET / ORAL | RLD | 2019-12-19 | 6a51e52b5d6a… |
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 |