DrugPatentWatch Database Preview
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. Additional details are available on the NETSPOT profile page.
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.
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 | ||||||||
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