Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202958
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
02/25/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202958Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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09/10/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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09/10/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/10/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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09/10/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/10/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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09/10/2020 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/25/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf |