N/A |
103810 |
1 |
351(a) |
Animal Allergens, Standardized Cat Hair |
Injection |
Percutaneous |
10,000BAU/ML |
Dropper Vial |
1971/12/16
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
|
N/A |
103810 |
2 |
351(a) |
Animal Allergens, Standardized Cat Hair |
Injection |
Subcutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1971/12/16
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
|
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose |
101141 |
1 |
351(a) |
Rho(D) Immune Globulin (Human) |
Injection |
Intramuscular |
1500IU |
Pre-Filled Syringe |
1971/06/11
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
|
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose |
101141 |
2 |
351(a) |
Rho(D) Immune Globulin (Human) |
Injection |
Intramuscular |
250IU |
Pre-Filled Syringe |
1971/06/11
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
|
M-M-R Ii |
101069 |
1 |
351(a) |
Measles, Mumps and Rubella Virus Vaccine Live |
For Injection |
Subcutaneous |
0.5ML |
Single-Dose Vial |
1971/04/22
|
Merck Sharp & Dohme LLC |
Rx |
Licensed |
|
|
Proplex-T; Bebulin |
103112 |
1 |
351(a) |
Factor IX Complex |
For Injection |
Intravenous |
200-1200U/20ML |
Vial |
1970/08/21
|
Baxalta US Inc. |
Rx |
Voluntarily Revoked |
|
|
Tdvax |
101322 |
1 |
351(a) |
Tetanus and Diphtheria Toxoids Adsorbed |
Injection |
Intramuscular |
0.5ML |
Single-Dose Vial |
1970/07/27
|
MassBiologics |
Rx |
Licensed |
|
|
MERUVAX II |
101075 |
1 |
351(a) |
Rubella Virus Vaccine Live |
For Injection |
Subcutaneous |
NLT1000U/.5ML |
Vial |
1969/06/09
|
Merck Sharp & Dohme LLC |
Disc |
Voluntarily Revoked |
|
|
MumpsVax |
101072 |
1 |
351(a) |
Mumps Virus Vaccine Live |
For Injection |
Subcutaneous |
0.5ML |
Vial |
1967/12/28
|
Merck Sharp & Dohme LLC |
Disc |
Voluntarily Revoked |
|
|
|
101099 |
1 |
351(a) |
Antivenin (Micrurus fulvius) |
For Injection |
Intravenous |
10ML |
Vial |
1967/08/28
|
Wyeth Pharmaceuticals LLC |
Disc |
Licensed |
|
|
Santyl |
101995 |
1 |
351(a) |
collagenase |
Ointment |
Topical |
250UNITS/GRAM |
Tube |
1965/06/04
|
Smith & Nephew, Inc. |
Rx |
Licensed |
|
|
Elase-chloromycetin |
050294 |
1 |
351(a) |
fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol |
Ointment |
Topical |
10MG/GM; 666UNITS/GM; 1UNIT/GM |
Tube |
1964/04/01
|
Parke-Davis, a Division of Pfizer Inc. |
Disc |
Voluntarily Revoked |
|
|
ATTENUVAX |
101068 |
1 |
351(a) |
Measles Virus Vaccine Live |
For Injection |
Subcutaneous |
NLT1000U/.5ML |
Vial |
1963/03/21
|
Merck Sharp & Dohme LLC |
Disc |
Voluntarily Revoked |
|
|
Plasmanate |
101140 |
1 |
351(a) |
Plasma Protein Fraction (Human) |
Injection |
Intravenous |
25G/500ML |
Single-Dose Vial |
1958/10/02
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
|
Plasmanate |
101140 |
2 |
351(a) |
Plasma Protein Fraction (Human) |
Injection |
Intravenous |
2.5G/50ML |
Single-Dose Vial |
1958/10/02
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
|
Plasmanate |
101140 |
3 |
351(a) |
Plasma Protein Fraction (Human) |
Injection |
Intravenous |
12.5G/250ML |
Single-Dose Vial |
1958/10/02
|
Grifols Therapeutics LLC |
Rx |
Licensed |
|
|
N/A |
103051 |
1 |
351(a) |
Pollens - Grasses, Bermuda Grass Cynodon dactylon |
Injection |
Subcutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1958/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
|
N/A |
103051 |
2 |
351(a) |
Pollens - Grasses, Bermuda Grass Cynodon dactylon |
Injection |
Percutaneous |
10,000BAU/ML |
Multi-Dose Vial |
1958/09/29
|
ALK-Abello, Inc. |
Rx |
Licensed |
|
|
N/A |
101834 |
1 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides farinae |
Injection |
Percutaneous |
10,000AU/ML |
Dropper Vial |
1958/09/15
|
Greer Laboratories, Inc. |
Rx |
Licensed |
|
|
N/A |
101834 |
2 |
351(a) |
Insects (Whole Body), Mite Dermatophagoides farinae |
Injection |
Intradermal |
5,000AU/ML |
Multi-Dose Vial |
1958/09/15
|
Greer Laboratories, Inc. |
Rx |
Licensed |
|
|