Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208424
Company: POHL BOSKAMP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GONITRO NITROGLYCERIN 0.4MG/PACKET POWDER;SUBLINGUAL 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
06/08/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208424s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208424Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208424Orig1toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/08/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208424s000lbl.pdf

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