Details for New Drug Application (NDA): 208547

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

Tradename:	NETSPOT
Applicant:	Aaa Usa Inc
Ingredient:	gallium dotatate ga-68
Patents:	1

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 208547

Dosage:

POWDER;INTRAVENOUS

^*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:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	2.1-5.5mCi/ML
Approval Date:	Jun 1, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 1, 2023
Regulatory Exclusivity Use:	FOR USE AFTER RADIOLABELING WITH GA 68, WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS.
Patent:		Patent Expiration:	Aug 10, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

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