Application 217795
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPIRAMATE | TOPIRAMATE | SOLUTION;ORAL | 25MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217795-001 | TOPIRAMATE | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217795-001 | AB |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| A217795-001 | PC | 2026-01-05 |
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 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217795-001 | TOPIRAMATE | 25MG/ML | SOLUTION / ORAL | AB | 2024-10-31 | 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 | A217795-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217795-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217795-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217795-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217795-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217795-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217795-001 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217795-001 | AB | 1 | d8e5a09893c0… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217795-001 | AB | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217795-001 | PC | 2026-01-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217795-001 | PC | 2026-01-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217795-001 | PC | 2026-01-05 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217795-001 | PC | 2026-01-05 | 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 |
|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | Kesin Pharma | 4e914420-a65b-98ba-e063-6394a90a14c4 | 2026-06-16 | Warnings, Adverse reactions | 217795 ANDA217795 |
| TOPIRAMATE | TOPIRAMATE | Ascend Laboratories, LLC | 7bc4ec7a-9b83-4842-9057-e1a804b2596d | 2026-03-13 | Warnings, Adverse reactions | 217795 ANDA217795 |
| TOPIRAMATE | TOPIRAMATE | Ascend Laboratories, LLC | 035bf713-1642-4215-83ec-0ed07c29f92c | 2026-03-13 | Warnings, Adverse reactions | 217795 ANDA217795 |