Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213049
Company: MSN

Products on ANDA 213049

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	AP	No	No
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213049Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213049

THIOTEPA

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL; 15MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEPADINA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	Yes	AP	208264	ADIENNE SA
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	214222	GLAND PHARMA LTD
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	213049	MSN

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL; 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEPADINA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	Yes	AP	208264	ADIENNE SA
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	214222	GLAND PHARMA LTD
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	213049	MSN