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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.
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 |
Generic Entry Opportunity Date for 208547
Generic Entry Date for 208547*:
Constraining patent/regulatory exclusivity:
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. | ||||||||
| Regulatory Exclusivity Expiration: | Jun 1, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 10, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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