Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214814
Company: MSN

Products on ANDA 214814

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214814

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214814

CARMUSTINE

INJECTABLE;INJECTION; 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BICNU	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	017422	AVET LIFESCIENCES
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215730	ALEMBIC
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211229	AMNEAL
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	213207	DR REDDYS
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211202	HENGRUI PHARMA
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	213460	MEITHEAL
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214814	MSN
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210179	NAVINTA LLC
CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209278	PENN LIFE