Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091430
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/12/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091430Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2016 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/03/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2016 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/22/2012 | SUPPL-1 | Labeling |
Label is not available on this site. |