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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090278
Company: SUN PHARM

Other Important Information from FDA

Products on ANDA 090278

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	AB	No	No
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	AB	No	No
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	AB	No	No
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090278

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
10/10/2023	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/30/2015	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/01/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/01/2014	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified		Label is not available on this site.
12/01/2014	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/27/2010	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/27/2010	SUPPL-3	REMS-Proposal		Label is not available on this site.

Therapeutic Equivalents for ANDA 090278

TOPIRAMATE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOPAMAX	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	Yes	AB	020505	JANSSEN PHARMS
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	076311	ACCORD HLTHCARE
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	215414	ASCENT PHARMS INC
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	078462	AUROBINDO PHARMA
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	076343	CIPLA LTD
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	077627	GLENMARK PHARMS LTD
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	079162	INVAGEN PHARMS
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	090278	SUN PHARM
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	090162	UNICHEM LABS LTD
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	077733	VIWIT PHARM
TOPIRAMATE	TOPIRAMATE	25MG	TABLET;ORAL	Prescription	No	AB	078235	ZYDUS PHARMS USA INC

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOPAMAX	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	Yes	AB	020505	JANSSEN PHARMS
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	076311	ACCORD HLTHCARE
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	215414	ASCENT PHARMS INC
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	078462	AUROBINDO PHARMA
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	076343	CIPLA LTD
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	077627	GLENMARK PHARMS LTD
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	079162	INVAGEN PHARMS
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	090278	SUN PHARM
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	090162	UNICHEM LABS LTD
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	077733	VIWIT PHARM
TOPIRAMATE	TOPIRAMATE	50MG	TABLET;ORAL	Prescription	No	AB	078235	ZYDUS PHARMS USA INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOPAMAX	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	Yes	AB	020505	JANSSEN PHARMS
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	076311	ACCORD HLTHCARE
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	215414	ASCENT PHARMS INC
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	078462	AUROBINDO PHARMA
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	076343	CIPLA LTD
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	077627	GLENMARK PHARMS LTD
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	079162	INVAGEN PHARMS
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	090278	SUN PHARM
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	090162	UNICHEM LABS LTD
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	077733	VIWIT PHARM
TOPIRAMATE	TOPIRAMATE	100MG	TABLET;ORAL	Prescription	No	AB	078235	ZYDUS PHARMS USA INC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOPAMAX	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	Yes	AB	020505	JANSSEN PHARMS
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	076311	ACCORD HLTHCARE
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	215414	ASCENT PHARMS INC
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	078462	AUROBINDO PHARMA
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	076343	CIPLA LTD
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	077627	GLENMARK PHARMS LTD
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	079162	INVAGEN PHARMS
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	090278	SUN PHARM
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	090162	UNICHEM LABS LTD
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	077733	VIWIT PHARM
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	078235	ZYDUS PHARMS USA INC

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