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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205366
Company: PAR STERILE PRODUCTS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS 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
12/07/2015 ORIG-2 Tentative Approval STANDARD

Label is not available on this site.
12/07/2015 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205366Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205366Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/07/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205366Orig1s000lbl.pdf
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