Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207382
Company: ZYDUS
Company: ZYDUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 11/24/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207382Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/18/2024 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/18/2024 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/09/2020 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/09/2020 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
TOPIRAMATE
CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |