Details for New Drug Application (NDA): 216984

NDA 216984 describes TEPYLUTE, which is a drug marketed by Shorla and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TEPYLUTE profile page.

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

Summary for 216984

Tradename:	TEPYLUTE
Applicant:	Shorla
Ingredient:	thiotepa
Patents:	1

Pharmacology for NDA: 216984

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 216984

Antineoplastic Agents, Alkylating

Myeloablative Agonists

Suppliers and Packaging for NDA: 216984

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEPYLUTE	thiotepa	SOLUTION;INTRAVENOUS	216984	NDA	Shorla Oncology Inc.	81927-105	81927-105-01	1 VIAL, SINGLE-DOSE in 1 CARTON (81927-105-01) / 1.5 mL in 1 VIAL, SINGLE-DOSE
TEPYLUTE	thiotepa	SOLUTION;INTRAVENOUS	216984	NDA	Shorla Oncology Inc.	81927-106	81927-106-01	1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	15MG/1.5ML (10MG/ML)
Approval Date:	Jun 25, 2024	TE:		RLD:	Yes
Patent:	11,975,013	Patent Expiration:	Aug 16, 2041	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MG/10ML (10MG/ML)
Approval Date:	Feb 26, 2025	TE:		RLD:	Yes
Patent:	11,975,013	Patent Expiration:	Aug 16, 2041	Product Flag?	Y	Substance Flag?		Delist Request?

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