Details for New Drug Application (NDA): 213049

NDA 213049 describes THIOTEPA, which is a drug marketed by Beloteca, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Teva Parenteral, West-ward Pharms Int, Gland Pharma Ltd, Hikma, Meitheal, and MSN, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the THIOTEPA profile page.

The generic ingredient in THIOTEPA is thiotepa. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

Summary for 213049

Tradename:	THIOTEPA
Applicant:	Msn
Ingredient:	thiotepa
Patents:	0

Pharmacology for NDA: 213049

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 213049

Antineoplastic Agents, Alkylating

Myeloablative Agonists

Suppliers and Packaging for NDA: 213049

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	213049	ANDA	MSN LABORATORIES PRIVATE LIMITED	69539-123	69539-123-01	1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	213049	ANDA	MSN LABORATORIES PRIVATE LIMITED	69539-124	69539-124-01	1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL			Strength	15MG/VIAL
Approval Date:	Mar 4, 2020	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL			Strength	100MG/VIAL
Approval Date:	Mar 4, 2020	TE:	AP	RLD:	No

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