Application 020364
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 2.5MG BASE;10MG | Yes | No |
| 003 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;10MG | Yes | No |
| 004 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;20MG | Yes | No |
| 005 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE;20MG | Yes | No |
| 006 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE;40MG | Yes | Yes |
| 007 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;40MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020364-002 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | RLD | 1995-03-03 | |
| N020364-003 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | RLD | 1995-03-03 | |
| N020364-004 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | RLD | 1995-03-03 | |
| N020364-005 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | RLD | 2002-06-20 | |
| N020364-006 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | RLD | 2006-04-11 | |
| N020364-007 | LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | RLD | 2006-04-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | RLD | 1995-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | RLD | 1995-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | RLD | 1995-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | RLD | 2002-06-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020364-006 | LOTREL | EQ 10MG BASE;40MG | CAPSULE / ORAL | RLD | 2006-04-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020364-007 | LOTREL | EQ 5MG BASE;40MG | CAPSULE / ORAL | RLD | 2006-04-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | RLD | 1995-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | RLD | 1995-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | RLD | 1995-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | RLD | 2002-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020364-006 | LOTREL | EQ 10MG BASE;40MG | CAPSULE / ORAL | RLD | 2006-04-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020364-007 | LOTREL | EQ 5MG BASE;40MG | CAPSULE / ORAL | RLD | 2006-04-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 2002-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020364-006 | LOTREL | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | RLD, RS | 2006-04-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020364-007 | LOTREL | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | RLD | 2006-04-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 2002-06-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020364-006 | LOTREL | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | RLD, RS | 2006-04-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020364-007 | LOTREL | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | RLD | 2006-04-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 2002-06-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020364-006 | LOTREL | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | RLD, RS | 2006-04-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020364-007 | LOTREL | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | RLD | 2006-04-11 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 2002-06-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020364-006 | LOTREL | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | RLD, RS | 2006-04-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020364-007 | LOTREL | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | RLD | 2006-04-11 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020364-002 | LOTREL | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020364-003 | LOTREL | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020364-004 | LOTREL | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 1995-03-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020364-005 | LOTREL | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | RLD | 2002-06-20 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | N020364-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020364-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020364-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020364-007 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020364-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020364-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020364-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020364-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020364-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020364-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020364-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020364-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020364-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020364-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020364-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020364-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020364-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020364-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020364-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020364-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020364-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020364-007 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020364-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020364-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020364-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020364-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020364-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020364-007 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020364-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020364-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020364-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020364-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020364-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020364-007 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020364-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020364-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020364-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020364-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020364-006 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020364-007 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0364 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0379 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0384 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0404 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0405 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0406 | Lotrel | amlodipine besylate and benazepril hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0615-1397 | amlodipine besylate and benazepril hydrochloride | amlodipine besylate and benazepril hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | NDA | Current |
| 0615-1398 | amlodipine besylate and benazepril hydrochloride | amlodipine besylate and benazepril hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | NDA | Current |
| 0615-1399 | amlodipine besylate and benazepril hydrochloride | amlodipine besylate and benazepril hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | NDA | Current |
| 0781-2271 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-2272 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-2273 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-2274 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-2277 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-2279 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 43063-233 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-039 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-096 | Lotrel | amlodipine besylate and benazepril hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 68151-1363 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
| 68151-1365 | Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate and benazepril hydrochloride | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67881 | SUPPL | 2021-06-24 |
| 67138 | SUPPL | 2021-04-22 |
| 61861 | SUPPL | 2020-02-11 |
| 61859 | SUPPL | 2020-02-11 |
| 49072 | SUPPL | 2017-07-25 |
| 49050 | SUPPL | 2017-07-25 |
| 34560 | SUPPL | 2015-05-21 |
| 24854 | SUPPL | 2015-05-19 |
| 12490 | SUPPL | 2015-04-24 |
| 24853 | SUPPL | 2015-04-23 |
| 34559 | SUPPL | 2015-01-05 |
| 24852 | SUPPL | 2014-12-30 |
| 24851 | SUPPL | 2012-10-10 |
| 2396 | SUPPL | 2012-10-10 |
| 34558 | SUPPL | 2012-10-09 |
| 12489 | SUPPL | 2012-10-09 |
| 34557 | SUPPL | 2012-01-23 |
| 24850 | SUPPL | 2012-01-23 |
| 12488 | SUPPL | 2011-11-01 |
| 2395 | SUPPL | 2011-10-31 |
| 34556 | SUPPL | 2011-07-07 |
| 24849 | SUPPL | 2011-06-29 |
| 24848 | SUPPL | 2011-01-07 |
| 12487 | SUPPL | 2011-01-05 |
| 34554 | SUPPL | 2010-04-04 |
| 24847 | SUPPL | 2010-04-02 |
| 2394 | SUPPL | 2010-01-05 |
| 34555 | SUPPL | 2010-01-04 |
| 24846 | SUPPL | 2009-11-19 |
| 12486 | SUPPL | 2009-10-30 |
| 24845 | SUPPL | 2007-09-06 |
| 12485 | SUPPL | 2007-09-04 |
| 2393 | SUPPL | 2007-03-06 |
| 24843 | SUPPL | 2006-04-13 |
| 12483 | SUPPL | 2006-04-12 |
| 2392 | SUPPL | 2004-08-12 |
| 12484 | SUPPL | 2004-07-07 |
| 24844 | SUPPL | 2004-07-06 |
| 2391 | SUPPL | 2003-09-09 |
| 20611 | SUPPL | 2002-11-22 |
| 24842 | SUPPL | 2002-06-20 |
| 12482 | SUPPL | 2002-06-20 |
| 41302 | SUPPL | 2001-08-21 |
| 34553 | SUPPL | 1999-06-16 |
| 24841 | SUPPL | 1999-06-16 |
| 41301 | SUPPL | 1997-03-14 |