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Last Updated: May 28, 2024

Details for New Drug Application (NDA): 208547

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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. There is one patent protecting this drug. Additional details are available on the NETSPOT profile page.

The generic ingredient in NETSPOT is gallium dotatate ga-68. There are sixteen 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 208547
Applicant:Aaa Usa Inc
Ingredient:gallium dotatate ga-68
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208547
Generic Entry Date for 208547*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 208547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NETSPOT 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength2.1-5.5mCi/ML
Approval Date:Jun 1, 2016TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 10, 2032Product Flag?YSubstance Flag?Delist Request?

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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 verification 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.