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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208159
Company: BTG INTL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISTOGARD URIDINE TRIACETATE 10GM/PACKET GRANULE;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/11/2015 ORIG-1 Approval PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208159Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208159Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208159Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/29/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208159s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208159Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/29/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208159s001lbl.pdf
12/11/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208159Orig1s000lbl.pdf
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