Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079107
Company: TOLMAR
Company: TOLMAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
01/15/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079107s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/03/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
11/03/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
11/03/2014 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/26/2012 | SUPPL-11 | Labeling-Package Insert, REMS |
Label is not available on this site. |
||
11/03/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
12/29/2010 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2009 | SUPPL-3 | Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |