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 | A-S Medication Solutions | a5cffe7a-fdee-487a-bafb-a2d43e76c23c | 2025-11-10 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | A-S Medication Solutions | c6918801-f22c-4ba4-a396-da484d4334ca | 2025-11-07 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | NCS HealthCare of KY, LLC dba Vangard Labs | 444464fb-6a95-4e10-99a7-fdbc7dbb4c48 | 2025-10-31 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Cardinal Health 107, LLC | e5bc696e-040d-4d3e-b38c-9548a38fa936 | 2025-10-13 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | be42ed09-350c-4e8a-aff4-6afb242dd599 | 2025-10-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals, Inc. | 2b6b0642-fb91-4641-9c51-d3be2021992b | 2025-10-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | American Health Packaging | 1af94c80-2b17-409a-98f6-ce00f942351d | 2025-09-30 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 83558f89-1adb-4d81-b19b-68721d48034b | 2025-09-30 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals, Inc. | d8454fdf-7b34-49c0-b130-732e39b774b2 | 2025-09-30 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Major Pharmaceuticals | 6fb00bd8-c49e-46ef-9d6b-1b602e1d11d8 | 2025-08-25 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | A-S Medication Solutions | 674c2c2e-014a-43a1-91a7-7214ffc4b1d7 | 2025-08-13 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | NuCare Pharmaceuticals, Inc. | 490f109f-30cb-0790-e054-00144ff88e88 | 2025-07-24 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 9e516204-8f39-43c9-9f7e-d9777586f321 | 2025-07-15 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | e39d2549-b489-426d-b576-741537e112e7 | 2025-07-15 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| TOPIRAMATE | TOPIRAMATE | XLCare Pharmaceuticals, Inc. | 546103e1-ea6e-466b-b0de-b1ff8c494512 | 2025-07-02 | Warnings, Adverse reactions | TOPIRAMATE TOPIRAMATE |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | f16b14a2-297f-4adb-8d7a-5f43785faef7 | 2025-06-09 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| TOPIRAMATE | TOPIRAMATE | Camber Pharmaceuticals, Inc. | cefbc5f4-ef5f-4732-ab96-a69a183f0b6b | 2025-05-22 | Warnings, Adverse reactions | TOPIRAMATE TOPIRAMATE |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 49701840-5a32-4ac1-8b07-5c61decacb95 | 2025-05-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | bf732c34-9078-496a-8093-f68594e76fcb | 2025-05-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 02cac021-e135-483f-bb5d-f3696eef0682 | 2025-05-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.