Details for New Drug Application (NDA): 212155
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NDA 212155 describes CERIANNA, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the CERIANNA profile page.
The generic ingredient in CERIANNA is fluoroestradiol f-18. One supplier is listed for this compound. Additional details are available on the fluoroestradiol f-18 profile page.
The generic ingredient in CERIANNA is fluoroestradiol f-18. One supplier is listed for this compound. Additional details are available on the fluoroestradiol f-18 profile page.
Summary for 212155
| Tradename: | CERIANNA |
| Applicant: | Ge Healthcare |
| Ingredient: | fluoroestradiol f-18 |
| Patents: | 0 |
Pharmacology for NDA: 212155
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 212155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CERIANNA | fluoroestradiol f-18 | SOLUTION;INTRAVENOUS | 212155 | NDA | GE Healthcare Inc. | 72874-001 | 72874-001-01 | 50 mL in 1 VIAL, MULTI-DOSE (72874-001-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50ML (4-100mCi/ML) | ||||
| Approval Date: | May 20, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 20, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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