DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 208547
The generic ingredient in NETSPOT is gallium dotatate ga-68. There are fifteen 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: | 0 |
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 | N | 69488-001-40 |
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. | ||||||||
Regulatory Exclusivity Expiration: | Jun 1, 2021 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY |
Complete Access Available with Subscription