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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078879
Company: HERITAGE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Discontinued None No No
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Discontinued None No No
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Discontinued None No No
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Discontinued None No No
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Discontinued None No No
TEMOZOLOMIDE TEMOZOLOMIDE 180MG 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
03/01/2010 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078879Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2022 SUPPL-18 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
11/14/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
11/23/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
11/23/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
11/23/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
04/30/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
09/13/2011 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
07/28/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.
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