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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201966
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION;INHALATION Discontinued None No No
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Discontinued None No No
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION 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
09/27/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/2021 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
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