Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078418
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | AB | No | No |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/14/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
12/23/2010 | SUPPL-1 | Labeling, REMS-Modified |
Label is not available on this site. |
TOPIRAMATE
CAPSULE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOPAMAX | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | Yes | AB | 020844 | JANSSEN PHARMS |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 215449 | AUROBINDO PHARMA LTD |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 078418 | STRIDES PHARMA |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 076575 | TEVA |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217694 | TWI PHARMS |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 078877 | ZYDUS PHARMS USA INC |
CAPSULE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOPAMAX | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 020844 | JANSSEN PHARMS |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 215449 | AUROBINDO PHARMA LTD |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 078418 | STRIDES PHARMA |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 076575 | TEVA |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217694 | TWI PHARMS |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 078877 | ZYDUS PHARMS USA INC |