Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218695
Company: AMTA
Company: AMTA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/03/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/01/2025 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
TOPIRAMATE
CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 219564 | AJANTA PHARMA LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 218695 | AMTA |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215638 | XIAMEN LP PHARM CO |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 219564 | AJANTA PHARMA LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 218695 | AMTA |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215638 | XIAMEN LP PHARM CO |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 219564 | AJANTA PHARMA LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 218695 | AMTA |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215638 | XIAMEN LP PHARM CO |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 219564 | AJANTA PHARMA LTD |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 218695 | AMTA |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215638 | XIAMEN LP PHARM CO |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 219564 | AJANTA PHARMA LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 218695 | AMTA |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215638 | XIAMEN LP PHARM CO |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |