Details for New Drug Application (NDA): 200655
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NDA 200655 describes FLUORODOPA F18, which is a drug marketed by Feinstein and is included in one NDA. It is available from one supplier. Additional details are available on the FLUORODOPA F18 profile page.
The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. One supplier is listed for this compound. Additional details are available on the fluorodopa f-18 profile page.
The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. One supplier is listed for this compound. Additional details are available on the fluorodopa f-18 profile page.
Summary for 200655
| Tradename: | FLUORODOPA F18 |
| Applicant: | Feinstein |
| Ingredient: | fluorodopa f-18 |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200655
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655 | NDA | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | 13267-345 | 13267-345-56 | 25 mL in 1 VIAL, GLASS (13267-345-56) |
| FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655 | NDA | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | 13267-346 | 13267-346-57 | 30 mL in 1 VIAL, GLASS (13267-346-57) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.42-8.33mCi/ML | ||||
| Approval Date: | Oct 10, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 10, 2024 | ||||||||
| Regulatory Exclusivity Use: | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 10, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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