|
103060 |
001 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides farinae |
Injection |
Percutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
N/A |
|
103060 |
002 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides farinae |
Injection |
Subcutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
N/A |
|
103061 |
001 |
351(a) |
Animal Allergens, Standardized Cat Pelt |
Injection |
Percutaneous |
10,000BAU/ML |
Dropper Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Voluntarily Revoked |
|
N/A |
|
103061 |
002 |
351(a) |
Animal Allergens, Standardized Cat Pelt |
Injection |
Subcutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Voluntarily Revoked |
|
N/A |
|
103752 |
001 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides pteronyssinus |
Injection |
Percutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
N/A |
|
103752 |
002 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides pteronyssinus |
Injection |
Subcutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
N/A |
| Histatrol |
103754 |
001 |
351(a) |
Positive Skin Test Control-Histamine |
Injection |
Intradermal |
0.1MG/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
N/A |
| Histatrol |
103754 |
002 |
351(a) |
Positive Skin Test Control-Histamine |
Injection |
Percutaneous |
1MG/ML |
Multi-Dose Vial |
1950/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
N/A |
| Baygam, Gamastan S/D |
101134 |
001 |
351(a) |
Immune Globulin (Human) |
Injection |
Intramuscular |
0.165 |
Single-Dose Vial |
1944/01/11
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
001 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
2.5G/50ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
002 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
25G/100ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
003 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
20G/100ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
004 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
10G/50ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
005 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
12.5G/50ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
006 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
5G/20ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
007 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
25G/500ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
| Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
101138 |
008 |
351(a) |
Albumin (Human) |
For Injection |
Intravenous |
12.5G/250ML |
Single-Dose Vial |
1942/10/21
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
N/A |
|
101062 |
001 |
351(a) |
Antivenin (Latrodectus mactans) |
For Injection |
Intravenous |
NLT6000U |
Single-Dose Vial |
1936/02/13
|
Merck Sharp & Dohme LLC |
Rx |
Licensed |
|
N/A |
|
101062 |
002 |
351(a) |
Antivenin (Latrodectus mactans) |
For Injection |
Intramuscular |
NLT6000U |
Single-Dose Vial |
1936/02/13
|
Merck Sharp & Dohme LLC |
Rx |
Licensed |
|
N/A |
|
101377 |
001 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides farinae |
Injection |
Subcutaneous |
10,000AU/ML |
Multi-Dose Vial |
1930/07/11
|
Allergy Laboratories, Inc. |
Disc |
Voluntarily Revoked |
|
N/A |