Application 213682
- Type
- ANDA
- Sponsor
- ALEMBIC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | TABLET;ORAL | 24MG;26MG | No | No |
| 002 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | TABLET;ORAL | 49MG;51MG | No | No |
| 003 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | TABLET;ORAL | 97MG;103MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213682-001 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | |
| A213682-002 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | |
| A213682-003 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213682-001 | AB |
| A213682-002 | AB |
| A213682-003 | 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 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213682-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-05-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213682-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-05-28 | 1e350fbaab3a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213682-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-05-28 | 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 | A213682-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213682-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213682-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213682-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213682-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213682-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213682-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213682-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213682-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213682-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213682-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213682-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213682-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213682-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213682-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213682-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213682-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213682-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213682-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213682-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213682-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213682-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213682-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213682-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213682-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213682-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213682-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213682-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213682-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213682-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213682-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213682-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213682-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213682-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213682-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213682-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213682-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213682-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213682-003 | AB | 1 | 1e350fbaab3a… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213682-001 | 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 |
|---|---|---|---|---|---|---|
| sacubitril and valsartan | SACUBITRIL AND VALSARTAN | Coupler LLC | 46154d5f-7de1-db5e-e063-6394a90af86e | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 213682 ANDA213682 |
| sacubitril and valsartan | SACUBITRIL AND VALSARTAN | Golden State Medical Supply, Inc. | 8290ae4c-0d1e-47f6-8029-ddc1c0bd6f6d | 2025-11-22 | Boxed warning, Warnings, Adverse reactions | 213682 ANDA213682 |
| sacubitril and valsartan | SACUBITRIL AND VALSARTAN | Alembic Pharmaceuticals Inc. | 5928f174-83e5-4c74-b15a-138338a70295 | 2024-11-03 | Boxed warning, Warnings, Adverse reactions | 213682 ANDA213682 |
| sacubitril and valsartan | SACUBITRIL AND VALSARTAN | Alembic Pharmaceuticals Limited | e4716fc9-5f73-4303-8a4e-e8f9129b6e2d | 2024-11-03 | Boxed warning, Warnings, Adverse reactions | 213682 ANDA213682 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78779 | ORIG | 2024-05-30 |