Details for New Drug Application (NDA): 022065

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NDA 022065 describes IXEMPRA KIT, which is a drug marketed by R-pharm Us Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the IXEMPRA KIT profile page.

The generic ingredient in IXEMPRA KIT is ixabepilone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ixabepilone profile page.

Summary for 022065

Tradename:	IXEMPRA KIT
Applicant:	R-pharm Us Llc
Ingredient:	ixabepilone
Patents:	1

Suppliers and Packaging for NDA: 022065

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1910	70020-1910-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE
IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1911	70020-1911-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	15MG/VIAL
Approval Date:	Oct 16, 2007	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 21, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	45MG/VIAL
Approval Date:	Oct 16, 2007	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 21, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022065

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007	⤷ Get Started Free	⤷ Get Started Free
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007	⤷ Get Started Free	⤷ Get Started Free
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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