Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078418
Company: STRIDES PHARMA

Products on ANDA 078418

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
TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078418

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
08/21/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/21/2025	SUPPL-11	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/21/2025	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/21/2025	SUPPL-8	Labeling-Patient Package Insert		Label is not available on this site.
08/21/2025	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/21/2025	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 078418

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

CAPSULE;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;ORAL	Prescription	No	AB	216683	RUBICON RESEARCH
TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE;ORAL	Prescription	No	AB	078418	STRIDES PHARMA
TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE;ORAL	Prescription	No	AB	078877	ZYDUS PHARMS USA INC