Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207382
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;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
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

TOPIRAMATE

CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB

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 AB 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 201635 SUPERNUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

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 AB 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 201635 SUPERNUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

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 AB 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 201635 SUPERNUS PHARMS

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