Drugs@FDA: FDA-Approved Drugs
Company: ZYDUS PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | AB | No | No |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
10/14/2009 | 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-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/25/2023 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/25/2023 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/07/2022 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/01/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/01/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/01/2020 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/01/2020 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/01/2020 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/01/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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10/30/2015 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/30/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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10/30/2015 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/18/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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11/18/2014 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/18/2014 | SUPPL-5 | Labeling-Medication Guide |
Label is not available on this site. |
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11/18/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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06/24/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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06/24/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
TOPIRAMATE
CAPSULE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOPAMAX | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | Yes | AB | 020844 | JANSSEN PHARMS |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 218482 | ALKEM LABS LTD |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 215449 | AUROBINDO PHARMA LTD |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217869 | GLENMARK PHARMS LTD |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 078418 | STRIDES PHARMA |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 076575 | TEVA |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217694 | TWI PHARMS |
TOPIRAMATE | TOPIRAMATE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 078877 | ZYDUS PHARMS USA INC |
CAPSULE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOPAMAX | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 020844 | JANSSEN PHARMS |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 218482 | ALKEM LABS LTD |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 215449 | AUROBINDO PHARMA LTD |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217869 | GLENMARK PHARMS LTD |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 078418 | STRIDES PHARMA |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 076575 | TEVA |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217694 | TWI PHARMS |
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 078877 | ZYDUS PHARMS USA INC |