Application 217279
- Type
- ANDA
- Sponsor
- ALEMBIC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 2.5MG BASE;EQ 10MG BASE | No | No |
| 002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 2.5MG BASE;EQ 20MG BASE | No | No |
| 003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 2.5MG BASE;EQ 40MG BASE | No | No |
| 004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 10MG BASE | No | No |
| 005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 20MG BASE | No | No |
| 006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 40MG BASE | No | No |
| 007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 80MG BASE | No | No |
| 008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 10MG BASE | No | No |
| 009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 20MG BASE | No | No |
| 010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 40MG BASE | No | No |
| 011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 80MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217279-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | |
| A217279-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217279-001 | AB |
| A217279-002 | AB |
| A217279-003 | AB |
| A217279-004 | AB |
| A217279-005 | AB |
| A217279-006 | AB |
| A217279-007 | AB |
| A217279-008 | AB |
| A217279-009 | AB |
| A217279-010 | AB |
| A217279-011 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217279-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2025-05-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217279-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-008 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-009 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-010 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217279-011 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-008 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-009 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-010 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217279-011 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-008 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-009 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-010 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217279-011 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-006 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217279-007 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Alembic Pharmaceuticals Inc. | 1346631f-e6db-4c5c-a6af-5aa7b80a011d | 2025-05-23 | Warnings, Adverse reactions | 217279 ANDA217279 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Alembic Pharmaceuticals Limited | ecab983e-6ed8-4440-b7b4-7ac4bf39b26c | 2025-05-23 | Warnings, Adverse reactions | 217279 ANDA217279 |