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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209150
Company: HENGRUI PHARMA

Products on ANDA 209150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209150

THIOTEPA

INJECTABLE;INJECTION; 15MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211831	BELOTECA
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210337	DR REDDYS
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209150	HENGRUI PHARMA
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	208242	PENN LIFE
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075547	WEST-WARD PHARMS INT

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