Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209936
Company: BAYER HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALIQOPA COPANLISIB DIHYDROCHLORIDE 60MG/VIAL POWDER;INTRAVENOUS 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
09/14/2017 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209936Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209936Orig1_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/12/2020 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209936s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209936Orig1s004ltr.pdf
10/28/2019 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209936Orig1s003ltr.pdf
05/24/2019 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209936Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/12/2020 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209936s004lbl.pdf
10/28/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s003lbl.pdf
05/24/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s002lbl.pdf
09/14/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf

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