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Details for New Drug Application (NDA): 022405

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NDA 022405 describes CAPRELSA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CAPRELSA profile page.

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

Summary for NDA: 022405

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022405

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 022405 NDA AstraZeneca Pharmaceuticals LP 0310-7820 0310-7820-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-7820-30)
TABLET;ORAL 022405 NDA AstraZeneca Pharmaceuticals LP 0310-7840 0310-7840-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-7840-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 6, 2011TE:RLD:Yes
Patent:8,067,427Patent Expiration:Aug 8, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:RE42353Patent Expiration:Jun 27, 2022Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Apr 6, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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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.