Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078235
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| 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 |
|---|---|---|---|---|---|
| 09/08/2023 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2023 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/25/2023 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2022 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2020 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/01/2020 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/01/2020 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2020 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2014 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2014 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2010 | SUPPL-2 | REMS-Proposal |
Label is not available on this site. |
||
| 01/13/2010 | 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 | 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 |
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 |