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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211001
Company: MEITHEAL

Products on ANDA 211001

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211001

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211001Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 211001

BENDAMUSTINE HYDROCHLORIDE

POWDER;INTRAVENOUS; 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;INTRAVENOUS	Prescription	No	AP	205574	ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	205376	DR REDDYS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214739	EUGIA PHARMA
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211001	MEITHEAL
TREANDA	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	022249	CEPHALON

POWDER;INTRAVENOUS; 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;INTRAVENOUS	Prescription	No	AP	205574	ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	205376	DR REDDYS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214739	EUGIA PHARMA
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211001	MEITHEAL
TREANDA	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	022249	CEPHALON

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