Register entry
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Data as of · How to read this entry
- Registered sites
- 5
- Active NDC listings
- 11
- Labeller names
- 3
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing1Labelling2Finished drug manufacture1Packaging1positron emission tomography drug production3
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | 16751 Trans Canada Highway, Kirkland, Quebec H9H 4J4, Canada (CAN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009003838243604761 |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | 635 Oglethorpe Street, Macon, Georgia (GA) 31201, United States (USA) | positron emission tomography drug production | 3006607900080871605 |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | 825 Executive Park Drive, Mobile, Alabama (AL) 36606, United States (USA) | positron emission tomography drug production | 3006563584080871701 |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | 5215 Langford Park Dr, Norcross, Georgia (GA) 30071, United States (USA) | positron emission tomography drug production | 3008754709080871737 |
| Jubilant Draximage (USA) Inc. | 790 Township Line Road Suite 325, Yardley, Pennsylvania (PA) 19067, United States (USA) | Labelling | 3014118270080981460 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 11 human prescription drug. By marketing category: NDA 7, ANDA 3, BLA 1.
| Dosage form | NDCs |
|---|---|
| injection, powder, for solution | 3 |
| injection, powder, lyophilized, for solution | 3 |
| injection, solution | 2 |
| capsule | 1 |
| kit | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 8 |
| oral | 2 |
| respiratory (inhalation) | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| jubilant draximage inc., dba jubilant radiopharma | 9 |
| jubilant draximage (usa) inc. | 1 |
| jubilant draximage inc | 1 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DRAXIMAGE DTPA | Kit for the preparation of Technetium Tc 99m Pentetate | injection, powder, lyophilized, for solution, intravenous, respiratory (inhalation) | 65174-288NDA |
| DRAXIMAGE MAA | Kit for the preparation of Technetium Tc 99m Albumin aggregated | injection, powder, for solution, intravenous | 65174-270BLA |
| Drax Exametazime | Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling | injection, powder, lyophilized, for solution, intravenous | 65174-200NDA |
| Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | injection, solution, intravenous | 60055-334ANDA |
| HICON | Sodium Iodide I 131 | solution, oral | 65174-880NDA |
| Kit for the Preparation of Technetium Tc 99m Sulfur Colloid | Technetium Tc 99m Sulfur Colloid Kit | kit | 65174-179ANDA |
| RUBY-FILL | Rubidium Rb 82 | injection, solution, intravenous | 65174-021NDA |
| Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | capsule, oral | 65174-461NDA |
| TECHNETIUM TC 99M SESTAMIBI | Technetium TC 99m Sestamibi | injection, powder, for solution, intravenous | 45548-141ANDA |
| TECHNETIUM Tc 99m MERTIATIDE | Technetium Tc 99m Mertiatide | injection, powder, lyophilized, for solution, intravenous | 65174-261NDA |
| Technetium Tc 99m Medronate | Technetium Tc 99m Medronate | injection, powder, for solution, intravenous | 65174-660NDA |
Neighbours
Registered in the same town
1- TransOx, Inc.Norcross, GA
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Enquiry
Common questions
- Is Jubilant DraxImage Inc., dba Jubilant Radiopharma FDA approved?
- Jubilant DraxImage Inc., dba Jubilant Radiopharma holds 5 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Jubilant DraxImage Inc., dba Jubilant Radiopharma's drugs manufactured?
- At registered sites in Canada, the United States. The FDA register lists Kirkland; Macon, GA; Mobile, AL; Norcross, GA; Yardley, PA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, positron emission tomography drug production.
- What drugs does Jubilant DraxImage Inc., dba Jubilant Radiopharma make?
- 11 products are listed under Jubilant DraxImage Inc., dba Jubilant Radiopharma in the openFDA NDC Directory, most often as injection, powder, for solution; injection, powder, lyophilized, for solution; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.