Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076327
Company: SUN PHARM INDS LTD
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 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
05/21/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/21/2018 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/21/2018 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-1 Labeling-Package Insert

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; 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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