Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020505
Company: JANSSEN PHARMS
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 |
|---|---|---|---|---|---|
| 05/03/2023 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020505s065,020844s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020505Orig1s065,020844Orig1s056ltr.pdf | |
| 10/20/2022 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s064,020844s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020505Orig1s064,020844Orig1s055ltr.pdf | |
| 06/30/2021 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020505s063,020844s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020505Orig1s063, 020844Orig1s054ltr.pdf | |
| 01/13/2022 | SUPPL-62 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020505Orig1s062; 20844Orig1s053ltr.pdf | |
| 06/08/2020 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020505s061,020844s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020505Orig1s061, 020844Orig1s052ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 05/03/2023 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020505s065,020844s056lbl.pdf | |
| 10/20/2022 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s064,020844s054lbl.pdf | |
| 01/13/2022 | SUPPL-62 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf | |
| 06/30/2021 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020505s063,020844s054lbl.pdf | |
| 06/08/2020 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020505s061,020844s052lbl.pdf | |
| 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 | 215414 | ASCENT PHARMS 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 PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | TABLET;ORAL | Prescription | No | AB | 079162 | INVAGEN PHARMS |
| TOPIRAMATE | TOPIRAMATE | 100MG | TABLET;ORAL | Prescription | No | AB | 090278 | SUN PHARM |
| TOPIRAMATE | TOPIRAMATE | 100MG | TABLET;ORAL | Prescription | No | AB | 090162 | UNICHEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | TABLET;ORAL | Prescription | No | AB | 077733 | VIWIT PHARM |
| 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 | 215414 | ASCENT PHARMS 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 PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | TABLET;ORAL | Prescription | No | AB | 079162 | INVAGEN PHARMS |
| TOPIRAMATE | TOPIRAMATE | 200MG | TABLET;ORAL | Prescription | No | AB | 090278 | SUN PHARM |
| TOPIRAMATE | TOPIRAMATE | 200MG | TABLET;ORAL | Prescription | No | AB | 090162 | UNICHEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | TABLET;ORAL | Prescription | No | AB | 077733 | VIWIT PHARM |
| 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 | 215414 | ASCENT PHARMS 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 PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | TABLET;ORAL | Prescription | No | AB | 079162 | INVAGEN PHARMS |
| TOPIRAMATE | TOPIRAMATE | 25MG | TABLET;ORAL | Prescription | No | AB | 090278 | SUN PHARM |
| TOPIRAMATE | TOPIRAMATE | 25MG | TABLET;ORAL | Prescription | No | AB | 090162 | UNICHEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | TABLET;ORAL | Prescription | No | AB | 077733 | VIWIT PHARM |
| 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 | 215414 | ASCENT PHARMS 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 PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Prescription | No | AB | 079162 | INVAGEN PHARMS |
| TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Prescription | No | AB | 090278 | SUN PHARM |
| TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Prescription | No | AB | 090162 | UNICHEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Prescription | No | AB | 077733 | VIWIT PHARM |
| TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Prescription | No | AB | 078235 | ZYDUS PHARMS USA INC |