Application 218381
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 15MG | No | No |
| 002 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 30MG | No | No |
| 003 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 45MG | No | No |
| 004 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 60MG | No | No |
| 005 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 90MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218381-001 | TOLVAPTAN | TOLVAPTAN | 15MG | TABLET / ORAL | AB2 | 2025-11-10 | |
| A218381-002 | TOLVAPTAN | TOLVAPTAN | 30MG | TABLET / ORAL | AB2 | 2025-11-10 | |
| A218381-003 | TOLVAPTAN | TOLVAPTAN | 45MG | TABLET / ORAL | AB | 2025-11-10 | |
| A218381-004 | TOLVAPTAN | TOLVAPTAN | 60MG | TABLET / ORAL | AB2 | 2025-11-10 | |
| A218381-005 | TOLVAPTAN | TOLVAPTAN | 90MG | TABLET / ORAL | AB | 2025-11-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218381-001 | AB2 |
| A218381-002 | AB2 |
| A218381-003 | AB |
| A218381-004 | AB2 |
| A218381-005 | 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 | A218381-001 | TOLVAPTAN | 15MG | TABLET / ORAL | AB2 | 2025-11-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-002 | TOLVAPTAN | 30MG | TABLET / ORAL | AB2 | 2025-11-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-003 | TOLVAPTAN | 45MG | TABLET / ORAL | AB | 2025-11-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-004 | TOLVAPTAN | 60MG | TABLET / ORAL | AB2 | 2025-11-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-005 | TOLVAPTAN | 90MG | TABLET / ORAL | AB | 2025-11-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-001 | TOLVAPTAN | 15MG | TABLET / ORAL | AB2 | 2025-11-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-002 | TOLVAPTAN | 30MG | TABLET / ORAL | AB2 | 2025-11-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-003 | TOLVAPTAN | 45MG | TABLET / ORAL | AB | 2025-11-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-004 | TOLVAPTAN | 60MG | TABLET / ORAL | AB2 | 2025-11-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-005 | TOLVAPTAN | 90MG | TABLET / ORAL | AB | 2025-11-10 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-001 | TOLVAPTAN | 15MG | TABLET / ORAL | AB2 | 2025-11-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-002 | TOLVAPTAN | 30MG | TABLET / ORAL | AB2 | 2025-11-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-003 | TOLVAPTAN | 45MG | TABLET / ORAL | AB | 2025-11-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-004 | TOLVAPTAN | 60MG | TABLET / ORAL | AB2 | 2025-11-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-005 | TOLVAPTAN | 90MG | TABLET / ORAL | AB | 2025-11-10 | 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 | A218381-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218381-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218381-005 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-001 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-002 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-004 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218381-005 | 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 |
|---|---|---|---|---|---|---|
| SAMSCA | TOLVAPTAN | Otsuka America Pharmaceutical, Inc. | 5526617c-c7b9-4556-886d-729bbabbc566 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | TOLVAPTAN |
| TOLVAPTAN | TOLVAPTAN | Northstar Rx LLC | c075d517-f4c8-469a-9f51-416ef61c6a83 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | TOLVAPTAN TOLVAPTAN |
| Jynarque | TOLVAPTAN | Otsuka America Pharmaceutical, Inc. | 3febc0a1-9e5a-4ce0-843d-210f21d862c4 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | TOLVAPTAN |
| tolvaptan | TOLVAPTAN | Apotex Corp. | d9fd11d0-4269-12fb-95cf-b3c11d75e479 | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | tolvaptan TOLVAPTAN |
| TOLVAPTAN | TOLVAPTAN | Lupin Pharmaceuticals, Inc. | 9ba38e23-ca66-4406-92af-bbb8fad00e16 | 2025-05-09 | Boxed warning, Warnings, Adverse reactions | TOLVAPTAN TOLVAPTAN |
| TOLVAPTAN | TOLVAPTAN | Novadoz Pharmaceuticals LLC | 92ce12f1-eae0-4c83-9a4e-a5181e08fa92 | 2023-06-14 | Boxed warning, Warnings, Adverse reactions | TOLVAPTAN TOLVAPTAN |
| Tolvaptan | TOLVAPTAN | Ascend Laboratories, LLC | dd71ee70-9435-4715-bee5-edbb5a8d7d7b | 2022-09-07 | Boxed warning, Warnings, Adverse reactions | Tolvaptan TOLVAPTAN |
| Tolvaptan | TOLVAPTAN | Camber Pharmaceuticals, Inc. | 6f4c5679-8490-45ec-bd34-1a569e3af850 | 2022-09-05 | Boxed warning, Warnings, Adverse reactions | Tolvaptan TOLVAPTAN |
| Tolvaptan | TOLVAPTAN | Endo USA, Inc. | 5b14ba2b-9f80-41d6-9613-f16d3cf37d25 | 2021-05-30 | Boxed warning, Warnings, Adverse reactions | Tolvaptan TOLVAPTAN |