Suppliers and packages for biologic ingredient: fibrin sealant (human)
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Suppliers and packages for biologic ingredient: fibrin sealant (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | ARTISS | fibrin sealant (human) | Frozen | 125266 | BLA | Baxter Healthcare Corporation | 0338-9637-01 | 2 mL in 1 SYRINGE, PLASTIC (0338-9637-01) |
| Baxter Healthcare Corporation | ARTISS | fibrin sealant (human) | Frozen | 125266 | BLA | Baxter Healthcare Corporation | 0338-9639-01 | 4 mL in 1 SYRINGE, PLASTIC (0338-9639-01) |
| Baxter Healthcare Corporation | ARTISS | fibrin sealant (human) | Frozen | 125266 | BLA | Baxter Healthcare Corporation | 0338-9641-01 | 10 mL in 1 SYRINGE, PLASTIC (0338-9641-01) |
| Instituto Grifols, S.a. | VISTASEAL | fibrin sealant (human) | Frozen | 125640 | BLA | GRIFOLS USA, LLC | 61953-0011-1 | 1 KIT in 1 PACKAGE, COMBINATION (61953-0011-1) * 1 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS |
| Instituto Grifols, S.a. | VISTASEAL | fibrin sealant (human) | Frozen | 125640 | BLA | GRIFOLS USA, LLC | 61953-0012-1 | 1 KIT in 1 PACKAGE, COMBINATION (61953-0012-1) * 2 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS |
| Instituto Grifols, S.a. | VISTASEAL | fibrin sealant (human) | Frozen | 125640 | BLA | GRIFOLS USA, LLC | 61953-0014-1 | 1 KIT in 1 PACKAGE, COMBINATION (61953-0014-1) * 5 mL in 1 SYRINGE, GLASS * 5 mL in 1 SYRINGE, GLASS |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage | >BLA | >NDA/ANDA | >Supplier | >Package Code | >Package |
