Application 219564
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 002 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 003 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 004 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 005 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219564-001 | TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | |
| A219564-002 | TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | |
| A219564-003 | TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | |
| A219564-004 | TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | |
| A219564-005 | TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219564-001 | AB2 |
| A219564-002 | AB2 |
| A219564-003 | AB2 |
| A219564-004 | AB2 |
| A219564-005 | AB2 |
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 | A219564-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219564-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219564-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219564-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219564-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A219564-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219564-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219564-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219564-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219564-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2025-09-02 | 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 | A219564-001 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219564-002 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219564-003 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219564-004 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219564-005 | AB2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A219564-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219564-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219564-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219564-004 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219564-005 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219564-005 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219564-005 | AB2 | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-001 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-002 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-003 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-004 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219564-005 | AB2 | 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 |
|---|---|---|---|---|---|---|
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 5424d59e-74f1-4c3c-b737-79e9776e0b60 | 2026-03-23 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| TOPIRAMATE | TOPIRAMATE | Camber Pharmaceuticals, Inc. | dbc52b16-b93d-4d83-942b-485c502db1fa | 2026-03-16 | Warnings, Adverse reactions | TOPIRAMATE TOPIRAMATE |
| TOPIRAMATE | TOPIRAMATE | Ascend Laboratories, LLC | 7bc4ec7a-9b83-4842-9057-e1a804b2596d | 2026-03-13 | Warnings, Adverse reactions | TOPIRAMATE TOPIRAMATE |
| TOPIRAMATE | TOPIRAMATE | Ascend Laboratories, LLC | 035bf713-1642-4215-83ec-0ed07c29f92c | 2026-03-13 | Warnings, Adverse reactions | TOPIRAMATE TOPIRAMATE |
| Topamax | TOPIRAMATE | Janssen Pharmaceuticals, Inc. | 21628112-0c47-11df-95b3-498d55d89593 | 2026-03-12 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | C | 164cb1f7-1a41-675f-e063-6294a90ae0dd | 2026-03-05 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Advanced Rx of Tennessee, LLC | 4b1d3130-cf3c-d7da-e063-6294a90a6079 | 2026-02-18 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | 7f1e4475-6326-47a3-a317-b04b74b7c109 | 2026-02-02 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | 55e71f43-1cd5-4efc-9641-fda0a09c30f0 | 2026-02-02 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Dr. Reddys Laboratories Inc. | f07d81bc-5090-fbc5-2945-557cf002849c | 2026-02-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 68b22d22-c2d3-4e90-b302-56f7cb731427 | 2026-01-28 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | AvKARE | 25b377f7-ea89-fb56-e063-6394a90a239d | 2026-01-19 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | afd4c2b9-b80c-b43a-e053-2995a90ac923 | 2026-01-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Northwind Health Company, LLC | ca45d478-7214-5bc7-e053-2995a90aa601 | 2026-01-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Northwind Health Company, LLC | ae63e0e2-ceb1-4cc7-88fa-92cfa4516960 | 2026-01-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | f3321dc5-0fb7-0d12-e053-2a95a90a9694 | 2026-01-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | ffd7be08-050e-dfcb-e053-6394a90ad286 | 2026-01-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Ascend Laboratories, LLC | cb966bcb-3af7-4dbe-b540-58d473b891e5 | 2025-12-18 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 1f327383-beb3-4d15-add6-5f1c749f2b3f | 2025-11-18 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Eprontia | TOPIRAMATE | Azurity Pharmaceuticals, Inc. | e2a4df59-fead-4a01-9021-9eda02c48010 | 2025-11-13 | Warnings, Adverse reactions | TOPIRAMATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.