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| Status | DIN | Company | Product | Class | PM See footnote1 | Schedule | # See footnote2 | A.I. name See footnote3 | Strength |
|---|---|---|---|---|---|---|---|---|---|
| Marketed | 02223708 | GRIFOLS THERAPEUTICS LLC | ALBUMIN (HUMAN) 25% SOLUTION USP | Human | Yes | Schedule D | 1 | ALBUMIN (HUMAN) | 25 % |
| Marketed | 02223694 | GRIFOLS THERAPEUTICS LLC | ALBUMIN (HUMAN) 5% SOLUTION, USP | Human | Yes | Schedule D | 1 | ALBUMIN (HUMAN) | 5 % |
| Cancelled Pre Market | 02223643 | GRIFOLS THERAPEUTICS LLC | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | Human | Yes | Schedule D | 1 | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 500 MG / VIAL |
| Cancelled Pre Market | 02223651 | GRIFOLS THERAPEUTICS LLC | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | Human | Yes | Schedule D | 1 | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1 G / VIAL |
| Marketed | 02486598 | GRIFOLS THERAPEUTICS LLC | GAMASTAN | Human | Yes | Schedule D | 1 | IMMUNOGLOBULIN (HUMAN) | 18 % |
| Cancelled Post Market | 02230579 | GRIFOLS THERAPEUTICS LLC | GAMASTAN S/D | Human | Yes | Schedule D | 1 | IMMUNOGLOBULIN (HUMAN) | 18 % |
| Marketed | 02247724 | GRIFOLS THERAPEUTICS LLC | GAMUNEX | Human | Yes | Schedule D | 1 | IMMUNOGLOBULIN (HUMAN) | 10 G / 100 ML |
| Marketed | 02520001 | GRIFOLS THERAPEUTICS LLC | HYPERHEP B | Human | Yes | Schedule D | 1 | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML |
| Marketed | 02520125 | GRIFOLS THERAPEUTICS LLC | HYPERHEP B | Human | No | Schedule D | 1 | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 110 UNIT / 0.5 ML |
| Approved | 02520133 | GRIFOLS THERAPEUTICS LLC | HYPERHEP B | Human | Yes | Schedule D | 1 | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML |
| Cancelled Post Market | 02230738 | GRIFOLS THERAPEUTICS LLC | HYPERHEP B S/D | Human | Yes | Schedule D | 1 | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML |
| Cancelled Post Market | 02379465 | GRIFOLS THERAPEUTICS LLC | HYPERHEP B S/D | Human | Yes | Schedule D | 1 | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML |
| Cancelled Pre Market | 02379473 | GRIFOLS THERAPEUTICS LLC | HYPERHEP B S/D | Human | Yes | Schedule D | 1 | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML |
| Marketed | 02486571 | GRIFOLS THERAPEUTICS LLC | HYPERRAB | Human | Yes | Schedule D | 1 | RABIES IMMUNOGLOBULIN (HUMAN) | 300 UNIT / ML |
| Cancelled Post Market | 02230700 | GRIFOLS THERAPEUTICS LLC | HYPERRAB S/D | Human | Yes | Schedule D | 1 | RABIES IMMUNOGLOBULIN (HUMAN) | 150 UNIT / ML |
| Cancelled Pre Market | 02243524 | GRIFOLS THERAPEUTICS LLC | HYPERRHO S/D FULL DOSE | Human | Yes | Schedule D | 1 | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) | 1500 UNIT / DOSE |
| Approved | 02379457 | GRIFOLS THERAPEUTICS LLC | HYPERRHO S/D FULL DOSE | Human | Yes | Schedule D | 1 | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) | 1500 UNIT / DOSE |
| Marketed | 02520087 | GRIFOLS THERAPEUTICS LLC | HYPERTET | Human | Yes | Schedule D | 1 | TETANUS IMMUNOGLOBULIN (HUMAN) | 250 UNIT / ML |
| Cancelled Post Market | 02230697 | GRIFOLS THERAPEUTICS LLC | HYPERTET S/D | Human | Yes | Schedule D | 1 | TETANUS IMMUNOGLOBULIN (HUMAN) | 250 UNIT / DOSE |
| Cancelled Pre Market | 02379619 | GRIFOLS THERAPEUTICS LLC | HYPERTET S/D | Human | Yes | Schedule D | 1 | TETANUS IMMUNOGLOBULIN (HUMAN) | 250 UNIT / DOSE |
| Marketed | 02277921 | GRIFOLS THERAPEUTICS LLC | IGIVNEX | Human | Yes | Schedule D | 1 | IMMUNOGLOBULIN (HUMAN) | 10 G / 100 ML |
| Cancelled Post Market | 02230647 | GRIFOLS THERAPEUTICS LLC | IMMUNE SERUM GLOBULIN (HUMAN) | Human | Yes | Schedule D | 1 | IMMUNOGLOBULIN (HUMAN) | 18 % |
| Dormant | 02189119 | GRIFOLS THERAPEUTICS LLC | PLASBUMIN-25 | Human | Yes | Schedule D | 1 | ALBUMIN (HUMAN) | 250 MG / ML |
| Marketed | 02189100 | GRIFOLS THERAPEUTICS LLC | PLASBUMIN-5 | Human | Yes | Schedule D | 1 | ALBUMIN (HUMAN) | 50 MG / ML |
| Marketed | 02204606 | GRIFOLS THERAPEUTICS LLC | PROLASTIN-C | Human | Yes | Schedule D | 1 | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1000 MG / VIAL |
| Approved | 02488787 | GRIFOLS THERAPEUTICS LLC | PROLASTIN-C LIQUID | Human | Yes | Schedule D | 1 | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1000 MG / 20 ML |
| Approved | 02543028 | GRIFOLS THERAPEUTICS LLC | PRONEXTICA LIQUID | Human | Yes | Schedule D | 1 | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1000 MG / 20 ML |
| Cancelled Post Market | 02269570 | GRIFOLS THERAPEUTICS LLC | STERILE WATER FOR INJECTION, USP | Human | No | Ethical | 1 | WATER | 100 % |
| Approved | 02189135 | GRIFOLS THERAPEUTICS LLC | THROMBATE III | Human | Yes | Schedule D | 1 | ANTITHROMBIN III (HUMAN) | 500 UNIT / VIAL |
| Cancelled Post Market | 02189143 | GRIFOLS THERAPEUTICS LLC | THROMBATE III | Human | Yes | Schedule D | 1 | ANTITHROMBIN III (HUMAN) | 1000 UNIT / VIAL |
| Approved | 02494426 | GRIFOLS THERAPEUTICS LLC | XEMBIFY | Human | Yes | Schedule D | 1 | IMMUNOGLOBULIN (HUMAN) | 20 % |
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