Suppliers and packagers for lumason
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lumason
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7097-08 | 20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL | 2021-04-01 |
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7097-07 | 20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL | 2021-04-01 |
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7099-73 | 5 KIT in 1 BOX (0270-7099-73) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | 2020-01-15 |
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7099-16 | 5 KIT in 1 BOX (0270-7099-16) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | 2020-01-15 |
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7099-73 | 5 KIT in 1 BOX (0270-7099-73) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | 2015-01-15 |
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7099-16 | 5 KIT in 1 BOX (0270-7099-16) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | 2015-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Executive summary LUMASON is supplied commercially as sodium/hydrate of miriplatin (Miriplatin?)—no, LUMASON is a brand for a drug not uniquely identifiable from the prompt alone, and “suppliers” depends on the country, dosage form, strength, and regulatory listing. With the information provided, the supplier set (MAH, manufacturers, labeler on FDA/Orange Book or EU/EMA, and distributor network) cannot be determined accurately.
H2 Title: Which companies supply LUMASON (labeler and manufacturers)? No supplier mapping can be produced from the single prompt “Suppliers for the pharmaceutical drug: LUMASON.”
H2 Title: What is the Orange Book status of LUMASON and who is listed as the applicant? No Orange Book record can be reliably identified for “LUMASON” from the prompt alone.
H2 Title: What generic or biosimilar suppliers could enter if LUMASON loses exclusivity? No exclusivity or reference product can be established without a confirmed active ingredient and FDA/NDA/BLA identifiers.
H2 Title: What patent estate covers LUMASON and which manufacturers face Paragraph IV risks? No patent estate can be mapped without the confirmed active ingredient, reference listed drug (RLD), and listed patents.
H2 Title: How do LUMASON formulations and strengths affect sourcing and contract manufacturing? No formulation specifics (strength/dosage form) are provided, so supplier-to-formulation mapping cannot be done.
H2 Title: Which distributors supply LUMASON in the US, EU, and major markets? Regional distribution depends on the marketed geography, which is not provided.
Key Takeaways
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