Application 022314
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;12.5MG;160MG | Yes | No |
| 002 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;25MG;160MG | Yes | No |
| 003 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;12.5MG;160MG | Yes | No |
| 004 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;25MG;160MG | Yes | No |
| 005 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;25MG;320MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022314-001 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 |
| N022314-002 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 |
| N022314-003 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 |
| N022314-004 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 |
| N022314-005 | EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022314-001 | AB |
| N022314-002 | AB |
| N022314-003 | AB |
| N022314-004 | AB |
| N022314-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-001 | EXFORGE HCT | EQ 5MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-002 | EXFORGE HCT | EQ 5MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-003 | EXFORGE HCT | EQ 10MG BASE;12.5MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-004 | EXFORGE HCT | EQ 10MG BASE;25MG;160MG | TABLET / ORAL | AB | RLD | 2009-04-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-005 | EXFORGE HCT | EQ 10MG BASE;25MG;320MG | TABLET / ORAL | AB | RLD, RS | 2009-04-30 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | N022314-001 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-002 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-003 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-004 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | N022314-005 | AB | 1 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-004 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022314-005 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022314-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022314-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022314-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022314-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022314-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022314-005 | AB | 1 | fd3edfee7708… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-001 | 8101599 | 2023-05-16 | Drug product | 2012-01-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-001 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-001 | 8475839*PED | 2023-11-16 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-002 | 8101599 | 2023-05-16 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-002 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-002 | 8475839*PED | 2023-11-16 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-003 | 8101599 | 2023-05-16 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-003 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-003 | 8475839*PED | 2023-11-16 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-004 | 8101599 | 2023-05-16 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-004 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-004 | 8475839*PED | 2023-11-16 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-005 | 8101599 | 2023-05-16 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-005 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022314-005 | 8475839*PED | 2023-11-16 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-001 | 8101599 | 2023-05-16 | Drug product | 2012-01-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022314-001 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022314-001 | 8475839*PED | 2023-11-16 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-002 | 8101599 | 2023-05-16 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-002 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022314-002 | 8475839*PED | 2023-11-16 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-003 | 8101599 | 2023-05-16 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-003 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022314-003 | 8475839*PED | 2023-11-16 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-004 | 8101599 | 2023-05-16 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-004 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022314-004 | 8475839*PED | 2023-11-16 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-005 | 8101599 | 2023-05-16 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022314-005 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022314-005 | 8475839*PED | 2023-11-16 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022314-001 | 8101599 | 2023-05-16 | Drug product | 2012-01-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022314-001 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022314-001 | 8475839*PED | 2023-11-16 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022314-002 | 8101599 | 2023-05-16 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022314-002 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022314-002 | 8475839*PED | 2023-11-16 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022314-003 | 8101599 | 2023-05-16 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022314-003 | 8475839 | 2023-05-16 | Drug product | 2013-08-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022314-003 | 8475839*PED | 2023-11-16 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022314-004 | 8101599 | 2023-05-16 | Drug product | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0559 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0560 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0561 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0562 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0563 | Exforge HCT | amlodipine valsartan and hydrochlorothiazide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0781-5756 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE | amlodipine valsartan and hydrochlorothiazide | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5760 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE | amlodipine valsartan and hydrochlorothiazide | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5771 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE | amlodipine valsartan and hydrochlorothiazide | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5787 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE | amlodipine valsartan and hydrochlorothiazide | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5794 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE | amlodipine valsartan and hydrochlorothiazide | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72400 | SUPPL | 2022-10-17 |
| 72311 | SUPPL | 2022-10-12 |
| 67995 | SUPPL | 2021-06-30 |
| 66321 | SUPPL | 2021-02-23 |
| 64380 | SUPPL | 2020-08-24 |
| 64336 | SUPPL | 2020-08-20 |
| 59063 | SUPPL | 2019-06-13 |
| 59060 | SUPPL | 2019-06-13 |
| 17233 | SUPPL | 2015-07-30 |
| 7222 | SUPPL | 2015-07-30 |
| 38560 | SUPPL | 2014-09-26 |
| 29582 | SUPPL | 2014-09-25 |
| 38559 | SUPPL | 2014-06-10 |
| 38558 | SUPPL | 2014-03-19 |
| 38557 | SUPPL | 2014-03-19 |
| 29581 | SUPPL | 2014-03-19 |
| 7221 | SUPPL | 2014-03-19 |
| 17232 | SUPPL | 2012-12-10 |
| 29580 | SUPPL | 2012-11-29 |
| 29579 | SUPPL | 2012-10-02 |
| 17231 | SUPPL | 2012-10-01 |
| 29576 | SUPPL | 2012-02-21 |
| 17229 | SUPPL | 2012-02-17 |
| 29578 | SUPPL | 2012-01-20 |
| 7220 | SUPPL | 2011-12-14 |
| 38556 | SUPPL | 2011-12-13 |
| 29577 | SUPPL | 2011-11-02 |
| 17230 | SUPPL | 2011-10-31 |
| 17228 | SUPPL | 2011-06-27 |
| 29575 | SUPPL | 2011-06-13 |
| 42489 | ORIG | 2009-09-02 |
| 24280 | ORIG | 2009-09-02 |
| 29574 | ORIG | 2009-05-14 |
| 17227 | ORIG | 2009-05-11 |