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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205574
Company: ACCORD HLTHCARE

Products on ANDA 205574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	AP	No	No
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2022	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205574Orig1s000ltr.pdf

Labels for ANDA 205574

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205574

BENDAMUSTINE HYDROCHLORIDE

POWDER;IV (INFUSION); 25MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205574	ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	204230	APOTEX
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205447	BRECKENRIDGE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205376	DR REDDYS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	214739	EUGIA PHARMA
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	211001	KINDOS
TREANDA	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	Yes	AP	022249	CEPHALON

POWDER;IV (INFUSION); 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205574	ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	204230	APOTEX
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205447	BRECKENRIDGE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205376	DR REDDYS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	214739	EUGIA PHARMA
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	211001	KINDOS
TREANDA	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	Yes	AP	022249	CEPHALON

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