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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021961
Company: SYNTHON PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIMVASTATIN SIMVASTATIN 10MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
SIMVASTATIN SIMVASTATIN 20MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
SIMVASTATIN SIMVASTATIN 40MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
SIMVASTATIN SIMVASTATIN 80MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes 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
10/09/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021961lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021961s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021961_simvastatin_toc.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/09/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021961lbl.pdf
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