Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077641
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| ZONISAMIDE | ZONISAMIDE | 25MG | 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/2005/077641ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/14/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/21/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |