An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 216078
Company: BAXTER HLTHCARE CORP

Products on NDA 216078

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216078

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216078s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216078Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216078Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216078s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216078Orig1s002ltr.pdf

Labels for NDA 216078

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216078s002lbl.pdf
12/15/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216078s000lbl.pdf

Therapeutic Equivalents for NDA 216078

BENDAMUSTINE HYDROCHLORIDE

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

Top