Application 213611
- Type
- ANDA
- Sponsor
- NOVUGEN PHARMA SDN
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 |
|---|---|---|---|---|---|---|---|
| A213611-001 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2025-07-16 | |
| A213611-002 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2025-07-16 | |
| A213611-003 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2025-07-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213611-001 | AB |
| A213611-002 | AB |
| A213611-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A213611-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2025-07-16 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A213611-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2025-07-16 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A213611-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2025-07-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A213611-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A213611-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A213611-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | American Health Packaging | d85015d5-f619-4a58-b6ab-5e39af3f79d8 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 213611 ANDA213611 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | Novugen Pharma (USA) LLC | 747eeb5c-ac2f-474f-b6d2-0586d12653a6 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 213611 ANDA213611 |
| Sacubitril and Valsartan | SACUBITRIL AND VALSARTAN | Novugen Pharma (USA) LLC | ec37696b-eaac-4c74-9328-94857ce998e5 | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | 213611 ANDA213611 |