Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076317
Company: TEVA

• Other Important Information from FDA

Products on ANDA 076317

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Discontinued	None	No	No
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Discontinued	None	No	No
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Discontinued	None	No	No
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076317

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2009	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
11/17/2014	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/17/2011	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified		Label is not available on this site.
12/23/2010	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/13/2010	SUPPL-3	REMS-Proposal		Label is not available on this site.
01/28/2010	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2009	SUPPL-1	Labeling		Label is not available on this site.