Application 210709
- Type
- NDA
- Sponsor
- NODEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEKTURNA | ALISKIREN HEMIFUMARATE | CAPSULE, PELLET;ORAL | EQ 37.5MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210709-001 | TEKTURNA | ALISKIREN HEMIFUMARATE | EQ 37.5MG BASE | CAPSULE, PELLET / ORAL | RLD | 2017-11-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N210709-001 | TEKTURNA | EQ 37.5MG BASE | CAPSULE, PELLET / ORAL | RLD | 2017-11-14 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N210709-001 | TEKTURNA | EQ 37.5MG BASE | CAPSULE, PELLET / ORAL | RLD | 2017-11-14 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210709-001 | TEKTURNA | EQ 37.5MG BASE | CAPSULE, PELLET / ORAL | RLD | 2017-11-14 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210709-001 | TEKTURNA | EQ 37.5MG BASE | CAPSULE, PELLET / ORAL | RLD | 2017-11-14 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N210709-001 | NP | 2020-11-14 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N210709-001 | PED | 2021-05-14 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N210709-001 | PED | 2021-05-14 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N210709-001 | PED | 2021-05-14 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N210709-001 | PED | 2021-05-14 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N210709-001 | NP | 2020-11-14 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N210709-001 | PED | 2021-05-14 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N210709-001 | NP | 2020-11-14 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N210709-001 | PED | 2021-05-14 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N210709-001 | NP | 2020-11-14 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N210709-001 | PED | 2021-05-14 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N210709-001 | NP | 2020-11-14 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N210709-001 | PED | 2021-05-14 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N210709-001 | NP | 2020-11-14 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N210709-001 | PED | 2021-05-14 | 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 |
|---|---|---|---|---|---|---|
| Tekturna | ALISKIREN HEMIFUMARATE | LXO US Inc. | 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2 | 2024-03-07 | Boxed warning, Warnings, Adverse reactions | Tekturna ALISKIREN HEMIFUMARATE |
| Aliskiren | ALISKIREN HEMIFUMARATE | Prasco Laboratories | 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | ALISKIREN HEMIFUMARATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.