Details for New Drug Application (NDA): 203137
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The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.
Summary for 203137
Tradename: | VIZAMYL |
Applicant: | Ge Healthcare |
Ingredient: | flutemetamol f-18 |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203137
Generic Entry Date for 203137*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;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.
Pharmacology for NDA: 203137
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203137
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137 | NDA | Medi-Physics, Inc. dba GE Healthcare | 17156-067 | 17156-067-30 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 40.5mCi/10ML (4.05mCi/ML) | ||||
Approval Date: | Oct 25, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 3, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | DIAGNOSTIC RADIOIMAGING | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 21, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 16, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 203137
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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