Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077637
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
12/22/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077637rev2.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/25/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/26/2015 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/26/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
07/31/2010 | SUPPL-4 | REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
02/26/2010 | SUPPL-3 | REMS-Proposal, Labeling-Container/Carton Labels |
Label is not available on this site. |