Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076317
Company: TEVA
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
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-Package Insert, Labeling-Medication Guide

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-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/17/2011 SUPPL-6 REMS-Modified, Labeling-Package Insert, Labeling-Medication Guide

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-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/22/2009 SUPPL-1 Labeling

Label is not available on this site.

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 077733 APOTEX 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 GENERICS
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 079162 INVAGEN PHARMS
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 078410 LUPIN
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 090278 SUN PHARM
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 076327 SUN PHARM INDS LTD
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 076317 TEVA
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 079153 TORRENT PHARMS
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 090162 UNICHEM LABS LTD
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Prescription No AB 078499 UPSHER SMITH LABS
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 077733 APOTEX 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 GENERICS
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 079162 INVAGEN PHARMS
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 078410 LUPIN
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 090278 SUN PHARM
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 076317 TEVA
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 079153 TORRENT PHARMS
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 090162 UNICHEM LABS LTD
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Prescription No AB 078499 UPSHER SMITH LABS
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 077733 APOTEX 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 GENERICS
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 079162 INVAGEN PHARMS
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 078410 LUPIN
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 090278 SUN PHARM
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 076327 SUN PHARM INDS LTD
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 076317 TEVA
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 079153 TORRENT PHARMS
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 090162 UNICHEM LABS LTD
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Prescription No AB 078499 UPSHER SMITH LABS
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 077733 APOTEX 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 GENERICS
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 079162 INVAGEN PHARMS
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 078410 LUPIN
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 090278 SUN PHARM
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 076327 SUN PHARM INDS LTD
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 076317 TEVA
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 079153 TORRENT PHARMS
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 090162 UNICHEM LABS LTD
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 078499 UPSHER SMITH LABS
TOPIRAMATE TOPIRAMATE 200MG TABLET;ORAL Prescription No AB 078235 ZYDUS PHARMS USA INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English