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Details for New Drug Application (NDA): 021711

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NDA 021711 describes ABLAVAR, which is a drug marketed by Lantheus Medcl 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 ABLAVAR profile page.

The generic ingredient in ABLAVAR is gadofosveset trisodium. One supplier is listed for this compound. Additional details are available on the gadofosveset trisodium profile page.

Summary for NDA: 021711

Tradename:
ABLAVAR
Applicant:
Lantheus Medcl
Ingredient:
gadofosveset trisodium
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021711

Suppliers and Packaging for NDA: 021711

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABLAVAR
gadofosveset trisodium
SOLUTION;INTRAVENOUS 021711 NDA Lantheus Medical Imaging, Inc. 11994-012 11994-012-01 10 VIAL in 1 BOX (11994-012-01) > 10 mL in 1 VIAL
ABLAVAR
gadofosveset trisodium
SOLUTION;INTRAVENOUS 021711 NDA Lantheus Medical Imaging, Inc. 11994-012 11994-012-02 10 VIAL in 1 BOX (11994-012-02) > 15 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength2440MG/10ML (244MG/ML)
Approval Date:Dec 22, 2008TE:RLD:No
Patent:6,676,929Patent Expiration:May 4, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength3660MG/15ML (244MG/ML)
Approval Date:Dec 22, 2008TE:RLD:No
Patent:6,676,929Patent Expiration:May 4, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021711

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lantheus Medcl
ABLAVAR
gadofosveset trisodium
SOLUTION;INTRAVENOUS021711-002Dec 22, 20087,229,606► subscribe
Lantheus Medcl
ABLAVAR
gadofosveset trisodium
SOLUTION;INTRAVENOUS021711-002Dec 22, 20085,362,475► subscribe
Lantheus Medcl
ABLAVAR
gadofosveset trisodium
SOLUTION;INTRAVENOUS021711-002Dec 22, 20087,011,815► subscribe
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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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