Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020505
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPAMAX TOPIRAMATE 100MG TABLET;ORAL Prescription AB Yes Yes
TOPAMAX TOPIRAMATE 200MG TABLET;ORAL Prescription AB Yes No
TOPAMAX TOPIRAMATE 300MG TABLET;ORAL Discontinued None No No
TOPAMAX TOPIRAMATE 25MG TABLET;ORAL Prescription AB Yes No
TOPAMAX TOPIRAMATE 50MG TABLET;ORAL Prescription AB Yes No
TOPAMAX TOPIRAMATE 400MG TABLET;ORAL Discontinued None 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
12/24/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020505s000_Topamax.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2019 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020505s060,020844s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020505Orig1s060, 020844Orig1s051ltr.pdf
12/27/2018 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s59_020844s50lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020505Orig1s059,020844Orig1s050ltr.pdf
06/19/2018 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s058_020844_49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020505Orig1s058,020844Orig1s049ltr.pdf
05/12/2017 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020505Orig1s057,020844Orig1s048ltr.pdf
05/11/2015 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

12/18/2014 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844Orig1s046ltr.pdf
10/21/2014 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s054,020844Orig1s045ltr.pdf
01/29/2014 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s053,020844Orig1s044ltr.pdf
03/28/2014 SUPPL-52 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844Orig1s043ltr.pdf
07/25/2013 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

10/29/2012 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020505s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050,020844Orig1s041ltr.pdf
06/27/2011 SUPPL-46 REMS-Assessment

Label is not available on this site.

03/04/2011 SUPPL-45 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf
07/15/2011 SUPPL-42 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s042,20844s36ltr.pdf
03/04/2011 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf
04/23/2009 SUPPL-39 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf
04/23/2009 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf
12/22/2009 SUPPL-37 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf
04/22/2009 SUPPL-36 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf
12/22/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf
12/22/2009 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf
10/19/2006 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029, 020844s024ltr.pdf
06/29/2005 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf
08/11/2004 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf
04/15/2003 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf
08/11/2004 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf
04/15/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf
06/12/2003 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr020,20844slr017ltr.pdf
12/16/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf
06/29/2005 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020505Orig1s018.pdf
12/16/2003 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf
11/26/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20505slr013,20844slr016ltr.pdf
06/03/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr015,20844slr012ltr.pdf
12/22/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf
10/24/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/18/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/2003 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf
01/04/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/07/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/02/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/01/2000 SUPPL-5 Labeling

Label is not available on this site.

10/01/1999 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax.cfm
08/28/2001 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20505S002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-505s002_20-844s010_Topamax.cfm
07/23/1999 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/02/2019 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020505s060,020844s051lbl.pdf
12/27/2018 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s59_020844s50lbl.pdf
06/19/2018 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s058_020844_49lbl.pdf
05/12/2017 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf
12/18/2014 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf
10/21/2014 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf
03/28/2014 SUPPL-52 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf
01/29/2014 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf
10/29/2012 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020505s050lbl.pdf
07/15/2011 SUPPL-42 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf
03/04/2011 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf
03/04/2011 SUPPL-45 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf
03/04/2011 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf
12/22/2009 SUPPL-37 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf
12/22/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf
12/22/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf
12/22/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf
04/23/2009 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf
04/23/2009 SUPPL-39 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf
04/23/2009 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf
04/22/2009 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf
06/29/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf
06/29/2005 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf
08/11/2004 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf
08/11/2004 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf
12/16/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf
12/16/2003 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf
12/16/2003 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf
08/28/2001 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20505S002lbl.pdf
10/01/1999 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf
07/23/1999 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf

TOPAMAX

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

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

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