Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208547

« Back to Dashboard
NDA 208547 describes NETSPOT, which is a drug marketed by Aaa Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the NETSPOT profile page.

The generic ingredient in NETSPOT is gallium dotatate ga-68. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium dotatate ga-68 profile page.

Summary for NDA: 208547


Suppliers and Packaging for NDA: 208547

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
gallium dotatate ga-68
POWDER;INTRAVENOUS 208547 NDA Advanced Accelerator Applications USA, Inc 69488-001 69488-001-40 1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength2.1-5.5mCi/ML
Approval Date:Jun 1, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 1, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 1, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:

Google Plus