Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079153
Company: TORRENT PHARMS
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079153s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2019 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

01/24/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/01/2014 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/29/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/01/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/14/2011 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/11/2010 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/21/2010 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

01/22/2010 SUPPL-3 REMS-Proposal, Labeling

Label is not available on this site.

01/22/2010 SUPPL-2 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

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