Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078877
Company: ZYDUS PHARMS USA INC

Products on ANDA 078877

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 078877

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
09/08/2023	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/25/2023	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/25/2023	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/07/2022	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/01/2020	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2020	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/01/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2020	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2020	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/18/2014	SUPPL-8	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-5	Labeling-Medication Guide		Label is not available on this site.
11/18/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078877

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