Application 213728
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
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 |
|---|---|---|---|---|---|---|---|
| A213728-001 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | |
| A213728-002 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | |
| A213728-003 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213728-001 | AB |
| A213728-002 | AB |
| A213728-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213728-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-10-16 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213728-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-10-16 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213728-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-10-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213728-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213728-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213728-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213728-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213728-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213728-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213728-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213728-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213728-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213728-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213728-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213728-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213728-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213728-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213728-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213728-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213728-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213728-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213728-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213728-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213728-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213728-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213728-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213728-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213728-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213728-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213728-003 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213728-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213728-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213728-003 | AB | 1 | d8e5a09893c0… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213728-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213728-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213728-003 | 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 | NorthStar RxLLC | 998db1e1-3f32-4812-a64b-5a6870ef7f8f | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 213728 ANDA213728 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | XLCare Pharmaceuticals Inc | 064a7c51-de30-4759-8210-e18438e6a187 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 213728 ANDA213728 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | Aphena Pharma Solutions - Tennessee, LLC | 487102e3-f319-836b-e063-6394a90a4438 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 213728 ANDA213728 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | Aphena Pharma Solutions - Tennessee, LLC | 4870fbeb-ce93-7953-e063-6294a90a6142 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 213728 ANDA213728 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | Aphena Pharma Solutions - Tennessee, LLC | 48714b95-b4ac-ef3c-e063-6294a90a9a5b | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 213728 ANDA213728 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | Macleods Pharmaceuticals Limited | 103c39e2-f3c8-40fc-a57e-3af018fb4af4 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | 213728 ANDA213728 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.