Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020617
Company: AVENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYTEST UREA, C-14 1uCi CAPSULE;ORAL Prescription None Yes Yes
PYTEST KIT UREA, C-14 1uCi CAPSULE;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
05/09/1997 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/31/2014 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

03/17/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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