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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 two suppliers. There are six patents 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. Two suppliers are listed for this compound. Additional details are available on the ixabepilone profile page.

Summary for NDA: 022065

Tradename:
IXEMPRA KIT
Applicant:
R-pharm Us Llc
Ingredient:
ixabepilone
Patents:6
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022065

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IXEMPRA KIT
ixabepilone
INJECTABLE;IV (INFUSION) 022065 NDA E.R. Squibb & Sons, L.L.C. 0015-1910 0015-1910-12 1 KIT in 1 PACKAGE, COMBINATION (0015-1910-12) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE
IXEMPRA KIT
ixabepilone
INJECTABLE;IV (INFUSION) 022065 NDA E.R. Squibb & Sons, L.L.C. 0015-1911 0015-1911-13 1 KIT in 1 PACKAGE, COMBINATION (0015-1911-13) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength15MG/VIAL
Approval Date:Oct 16, 2007TE:RLD:Yes
Patent:6,670,384*PEDPatent Expiration:Jul 23, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:7,022,330*PEDPatent Expiration:Jul 23, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:7,125,899*PEDPatent Expiration:Nov 26, 2018Product Flag?Substance Flag?Delist Request?Y


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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