Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206289
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS;OPHTHALMIC 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
07/18/2014 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206289Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf

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