Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076575
Company: TEVA

Products on ANDA 076575

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2009	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
01/09/2024	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/09/2024	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/18/2014	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/18/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/18/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/18/2014	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/14/2011	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal		Label is not available on this site.
10/30/2010	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/30/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076575

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