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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205580
Company: EAGLE PHARMS

Products on NDA 205580

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2018	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/2018/205580s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205580s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205580Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205580s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205580Orig1s013ltr.pdf
06/02/2022	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205580Orig1s012Corrected_ltr.pdf
10/14/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205580Orig1s010ltr.pdf
10/30/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205580Orig1s006ltr.pdf
08/31/2018	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf

Labels for NDA 205580

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205580s013lbl.pdf
06/02/2022	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf
06/02/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf
10/14/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf
10/30/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf
08/31/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf
08/31/2018	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf
05/15/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf

Therapeutic Equivalents for NDA 205580

BELRAPZO

SOLUTION;INTRAVENOUS; 100MG/4ML (25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	205580	EAGLE PHARMS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	215033	APOTEX
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	216078	BAXTER HLTHCARE CORP

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