Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091338
Company: TORRENT PHARMS LTD
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
05/29/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/091338Orig1s000OtherActionLtrs.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2020 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/18/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/04/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/04/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

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