Application 200465
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | ||
| A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | ||
| A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | ||
| A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200465-004 | AB |
| A200465-005 | AB |
| A200465-006 | AB |
| A200465-007 | AB |
| A200465-008 | AB |
| A200465-009 | AB |
| A200465-010 | AB |
| A200465-011 | 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 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200465-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-008 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-009 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-010 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-011 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-008 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-009 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-010 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-011 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-008 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-009 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-010 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-011 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-008 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-009 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-010 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-011 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-008 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-009 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-010 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-011 | AB | 1 | b8a1b40f171c… |
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 | Mylan Pharmaceuticals Inc. | 4be76756-4114-4d50-a36c-fd410f6c773d | 2024-11-11 | Warnings, Adverse reactions | 200465 ANDA200465 0378-4519 0378-4517 0378-4518 0378-4515 0378-4516 0378-4513 0378-4520 0378-4514 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4510 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4510 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4511 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4511 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4512 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4512 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4513 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4513 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4513 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4513 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4513 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4514 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4514 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4514 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4514 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4514 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4515 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4515 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4515 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4515 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4515 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4516 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4516 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4516 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4516 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4516 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4517 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4517 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4517 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4517 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4517 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4518 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4518 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4518 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4518 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4518 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4519 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4519 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4519 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4519 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4519 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4520 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4520 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4520 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4520 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4520 | Amlodipine and atorvastatin | Amlodipine and atorvastatin | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32023 | ORIG | 2013-12-05 |