Details for New Drug Application (NDA): 202153
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NDA 202153 describes RUBY-FILL, which is a drug marketed by Jubilant and is included in one NDA. It is available from one supplier. Additional details are available on the RUBY-FILL profile page.
The generic ingredient in RUBY-FILL is rubidium chloride rb-82. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rubidium chloride rb-82 profile page.
The generic ingredient in RUBY-FILL is rubidium chloride rb-82. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rubidium chloride rb-82 profile page.
Summary for 202153
| Tradename: | RUBY-FILL |
| Applicant: | Jubilant |
| Ingredient: | rubidium chloride rb-82 |
| Patents: | 0 |
Pharmacology for NDA: 202153
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 202153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RUBY-FILL | rubidium chloride rb-82 | SOLUTION;INTRAVENOUS | 202153 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-021 | 65174-021-10 | 1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | N/A | ||||
| Approval Date: | Sep 30, 2016 | TE: | RLD: | No | |||||
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