Details for New Drug Application (NDA): 201023

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NDA 201023 describes JEVTANA KIT, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the JEVTANA KIT profile page.

The generic ingredient in JEVTANA KIT is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.

Summary for 201023

Tradename:	JEVTANA KIT
Applicant:	Sanofi Aventis Us
Ingredient:	cabazitaxel
Patents:	4

Suppliers and Packaging for NDA: 201023

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023	NDA	Sanofi-Aventis U.S. LLC	0024-5824	0024-5824-11	1 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/1.5ML (40MG/ML)
Approval Date:	Jun 17, 2010	TE:	AP	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 27, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	INCREASING SURVIVAL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL BY ADMINISTERING AS A 3 WEEK CYCLE CABAZITAXEL AFTER 5 MG DEXCHLORPHENIRAMINE, 8 MG DEXAMETHASONE, AND AN H2-AGONIST
Patent:	⤷ Sign Up	Patent Expiration:	Oct 27, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	INCREASING SURVIVAL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL BY ADMINISTERING 20 TO 25 MG/M2 CABAZITAXEL AFTER A PREMEDICATION REGIMEN THAT INCLUDES AN H2-ANTAGONIST
Patent:	⤷ Sign Up	Patent Expiration:	Jun 10, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 201023

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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