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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208151
Company: ALCON LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOPTO ATROPINE 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
12/01/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208151lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208151Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208151Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/12/2022 SUPPL-3 Manufacturing (CMC)-Manufacturing Process Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208151Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208151Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/12/2022 SUPPL-3 Manufacturing (CMC)-Manufacturing Process Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208151Orig1s003lbl.pdf
12/01/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208151lbl.pdf
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