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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078499
Company: AIPING PHARM INC

Products on ANDA 078499

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 078499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2010	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
06/15/2026	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/19/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/19/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/17/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/17/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/17/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078499

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	078499	AIPING PHARM INC
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	090162	UNICHEM LABS LTD
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	078499	AIPING PHARM INC
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	090162	UNICHEM LABS LTD
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	078499	AIPING PHARM INC
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	090162	UNICHEM LABS LTD
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	078499	AIPING PHARM INC
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	090162	UNICHEM LABS LTD
TOPIRAMATE	TOPIRAMATE	200MG	TABLET;ORAL	Prescription	No	AB	078235	ZYDUS PHARMS USA INC

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