Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208536
Company: MYLAN INSTITUTIONAL

Products on ANDA 208536

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208536

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208536

BUSULFAN

INJECTABLE;INJECTION; 6MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210148	ACCORD HLTHCARE INC
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209580	AMNEAL
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205672	HOSPIRA
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212127	MEITHEAL
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208536	MYLAN INSTITUTIONAL
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207050	PHARMASCIENCE INC
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215235	PRINSTON INC
BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210931	SHILPA
BUSULFEX	BUSULFAN	6MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020954	OTSUKA PHARM