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Drugs@FDA: FDA-Approved Drugs

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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 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
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
04/09/2020 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/09/2020 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

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 207382 ZYDUS PHARMS
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 207382 ZYDUS PHARMS
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 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB1 201635 SUPERNUS PHARMS
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