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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209936
Company: BAYER HEALTHCARE

Products on NDA 209936

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALIQOPA	COPANLISIB DIHYDROCHLORIDE	60MG/VIAL	POWDER;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209936

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
09/07/2023	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209936Orig1s012ltr.pdf
03/30/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209936Orig1s011ltr.pdf
02/23/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209936s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209936Orig1s010ltr.pdf
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

Labels for NDA 209936

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s012lbl.pdf
09/07/2023	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s012lbl.pdf
03/30/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s011lbl.pdf
02/23/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209936s010lbl.pdf
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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