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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208194
Company: EAGLE PHARMS

Products on NDA 208194

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENDEKA	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION;IV (INFUSION)	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208194

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208194Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208194Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2024	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208194s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208194Orig1s026ltr.pdf
10/14/2021	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208194s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208194Orig1s024ltr.pdf
11/08/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208194Orig1s020ltr.pdf
10/08/2019	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208194Orig1s019ltr.pdf
07/30/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208194s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208194Orig1s013ltr.pdf
02/09/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208194Orig1s005ltr.pdf
02/06/2017	SUPPL-4		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208194Orig1s004.pdf
09/23/2016	SUPPL-3		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208194Orig1s003.pdf
06/23/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002ltr.pdf
06/23/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002ltr.pdf

Labels for NDA 208194

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2024	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208194s026lbl.pdf
10/14/2021	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208194s024lbl.pdf
11/08/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s020lbl.pdf
10/08/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s019lbl.pdf
07/30/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208194s013lbl.pdf
02/09/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf
06/23/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf
06/23/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf
12/07/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf

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