Application 205199
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 10MG BASE | No | No |
| 002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 20MG BASE | No | No |
| 003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 40MG BASE | No | No |
| 004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 5MG BASE;EQ 80MG BASE | No | No |
| 005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 10MG BASE | No | No |
| 006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 20MG BASE | No | No |
| 007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE;EQ 40MG BASE | No | No |
| 008 | 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 |
|---|---|---|---|---|---|---|---|
| A205199-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | |
| A205199-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205199-001 | AB |
| A205199-002 | AB |
| A205199-003 | AB |
| A205199-004 | AB |
| A205199-005 | AB |
| A205199-006 | AB |
| A205199-007 | AB |
| A205199-008 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205199-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205199-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2019-11-18 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205199-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205199-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205199-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205199-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205199-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205199-008 | AB | 1 | fd3edfee7708… |
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 | Bryant Ranch Prepack | bed1710f-edd9-488d-855b-603d50ee212c | 2026-03-20 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Bryant Ranch Prepack | ba6f6ab5-b65a-4486-b994-2d8bbbe650af | 2026-03-20 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Bryant Ranch Prepack | 5d7ca186-f22b-465f-913b-c020240b2c66 | 2026-03-20 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Bryant Ranch Prepack | 50112e22-5a69-47c9-90cd-82bbacae7418 | 2026-03-20 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Bryant Ranch Prepack | 9654e50b-811a-4c89-b1ab-f48418b204c1 | 2026-03-20 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Bryant Ranch Prepack | 043c4742-081d-4bc4-bf27-dad92bb2dfbc | 2026-02-12 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Bryant Ranch Prepack | be709711-e7ee-403f-ad43-873761deee37 | 2025-10-30 | Warnings, Adverse reactions | 205199 ANDA205199 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Apotex Corp. | 4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03 | 2025-10-20 | Warnings, Adverse reactions | 205199 ANDA205199 60505-3478 60505-3479 60505-3492 60505-3489 60505-3488 60505-3493 60505-3484 60505-3483 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-3478 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3478 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3478 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3479 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3479 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3479 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3483 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3483 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3483 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3484 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3484 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3484 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3488 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3488 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3488 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3489 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3489 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3489 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3492 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3492 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3492 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3493 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3493 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |
| 60505-3493 | Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | Apotex Corp. | ANDA | Current |