Details for New Drug Application (NDA): 216037

NDA 216037 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 216037

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

Pharmacology for NDA: 216037

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 216037

Antineoplastic Agents, Alkylating

Myeloablative Agonists

Suppliers and Packaging for NDA: 216037

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	216037	ANDA	Meitheal Pharmaceuticals Inc	71288-156	71288-156-05	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	216037	ANDA	Meitheal Pharmaceuticals Inc	71288-157	71288-157-10	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL			Strength	15MG/VIAL
Approval Date:	Dec 26, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL			Strength	100MG/VIAL
Approval Date:	Dec 26, 2023	TE:	AP	RLD:	No

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