Application 022107
- Type
- NDA
- Sponsor
- NODEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 150MG BASE;12.5MG | Yes | No |
| 002 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 150MG BASE;25MG | Yes | No |
| 003 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;12.5MG | Yes | Yes |
| 004 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;25MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022107-001 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | |
| N022107-002 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | |
| N022107-003 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | |
| N022107-004 | TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022107-001 | 8618172 | 2028-07-13 | Drug product | ||
| N022107-002 | 8618172 | 2028-07-13 | Drug product | ||
| N022107-003 | 8618172 | 2028-07-13 | Drug product | ||
| N022107-004 | 8618172 | 2028-07-13 | Drug product |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-001 | TEKTURNA HCT | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-002 | TEKTURNA HCT | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-003 | TEKTURNA HCT | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-004 | TEKTURNA HCT | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2008-01-18 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022107-001 | 8618172 | 2028-07-13 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022107-002 | 8618172 | 2028-07-13 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022107-003 | 8618172 | 2028-07-13 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022107-004 | 8618172 | 2028-07-13 | Drug product | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022107-001 | 8618172 | 2028-07-13 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022107-002 | 8618172 | 2028-07-13 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022107-003 | 8618172 | 2028-07-13 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022107-004 | 8618172 | 2028-07-13 | Drug product | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-001 | 8618172 | 2028-07-13 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-002 | 8618172 | 2028-07-13 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-003 | 8618172 | 2028-07-13 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022107-004 | 8618172 | 2028-07-13 | Drug product | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022107-001 | 8618172 | 2028-07-13 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022107-002 | 8618172 | 2028-07-13 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022107-003 | 8618172 | 2028-07-13 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022107-004 | 8618172 | 2028-07-13 | Drug product | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-001 | 8618172 | 2028-07-13 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-002 | 8618172 | 2028-07-13 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-003 | 8618172 | 2028-07-13 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022107-004 | 8618172 | 2028-07-13 | Drug product | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-001 | 8618172 | 2028-07-13 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-002 | 8618172 | 2028-07-13 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-003 | 8618172 | 2028-07-13 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022107-004 | 8618172 | 2028-07-13 | Drug product | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-001 | 8618172 | 2028-07-13 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-002 | 8618172 | 2028-07-13 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-003 | 8618172 | 2028-07-13 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022107-004 | 8618172 | 2028-07-13 | Drug product | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-001 | 8618172 | 2028-07-13 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-002 | 8618172 | 2028-07-13 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-003 | 8618172 | 2028-07-13 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022107-004 | 8618172 | 2028-07-13 | Drug product | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-001 | 8618172 | 2028-07-13 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-002 | 8618172 | 2028-07-13 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-003 | 8618172 | 2028-07-13 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022107-004 | 8618172 | 2028-07-13 | Drug product | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-001 | 8618172 | 2028-07-13 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-002 | 8618172 | 2028-07-13 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-003 | 8618172 | 2028-07-13 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022107-004 | 8618172 | 2028-07-13 | Drug product | d8e5a09893c0… |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70839-112 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-112 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-112 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-112 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-112 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-125 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-125 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-125 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-125 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-125 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-312 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-312 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-312 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-312 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-312 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-325 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-325 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-325 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-325 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
| 70839-325 | Tekturna HCT | aliskiren hemifumarate and hydrochlorothiazide | Noden Pharma USA, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64776 | SUPPL | 2020-10-01 |
| 64768 | SUPPL | 2020-10-01 |
| 45853 | SUPPL | 2016-11-08 |
| 45831 | SUPPL | 2016-11-08 |
| 38259 | SUPPL | 2015-12-28 |
| 29258 | SUPPL | 2015-12-23 |
| 16951 | SUPPL | 2015-04-02 |
| 29257 | SUPPL | 2015-04-01 |
| 16950 | SUPPL | 2014-03-19 |
| 6903 | SUPPL | 2013-11-07 |
| 38258 | SUPPL | 2013-11-04 |
| 6902 | SUPPL | 2012-10-02 |
| 16949 | SUPPL | 2012-10-01 |
| 6901 | SUPPL | 2012-04-18 |
| 38257 | SUPPL | 2012-04-16 |
| 38255 | SUPPL | 2012-02-17 |
| 6898 | SUPPL | 2012-02-17 |
| 6900 | SUPPL | 2012-02-14 |
| 38256 | SUPPL | 2012-01-31 |
| 6899 | SUPPL | 2012-01-30 |
| 16948 | SUPPL | 2011-10-20 |
| 6897 | SUPPL | 2011-10-14 |
| 38254 | SUPPL | 2011-06-16 |
| 6896 | SUPPL | 2011-06-16 |
| 6895 | SUPPL | 2011-02-14 |
| 38253 | SUPPL | 2011-02-11 |
| 29256 | SUPPL | 2010-08-11 |
| 16947 | SUPPL | 2010-08-09 |
| 38252 | SUPPL | 2010-05-28 |
| 6894 | SUPPL | 2010-05-24 |
| 16946 | SUPPL | 2009-07-24 |
| 6893 | SUPPL | 2009-07-17 |
| 44680 | ORIG | 2008-10-27 |
| 42416 | ORIG | 2008-10-27 |
| 29255 | SUPPL | 2008-07-23 |
| 38251 | ORIG | 2008-01-23 |
| 6892 | ORIG | 2008-01-23 |