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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215449
Company: AUROBINDO PHARMA LTD

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
09/27/2023 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
07/23/2025 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

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 218482 ALKEM LABS LTD
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 215449 AUROBINDO PHARMA LTD
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 217869 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 216683 RUBICON RESEARCH
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 218642 SENORES PHARMS
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 078418 STRIDES PHARMA
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 218482 ALKEM LABS LTD
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 215449 AUROBINDO PHARMA LTD
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 217869 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 216683 RUBICON RESEARCH
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 218642 SENORES PHARMS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 078418 STRIDES PHARMA
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 217694 TWI PHARMS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 078877 ZYDUS PHARMS USA INC
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