| CBER |
| 2 |
| Measles Virus Vaccine Live |
| ATTENUVAX |
| 101069 | Merck Sharp & Dohme LLC | 351(a) | CBER | 2 | Measles, Mumps and Rubella Virus Vaccine Live | M-M-R Ii |
| 101072 | Merck Sharp & Dohme LLC | 351(a) | CBER | 2 | Mumps Virus Vaccine Live | MumpsVax |
| 101075 | Merck Sharp & Dohme LLC | 351(a) | CBER | 2 | Rubella Virus Vaccine Live | MERUVAX II |
| 101094 | Merck Sharp & Dohme LLC | 351(a) | CBER | 2 | Pneumococcal Vaccine, Polyvalent | Pneumovax 23 |
| 101098 | Wyeth Pharmaceuticals LLC | 351(a) | CBER | 3 | Antivenin (Crotalidae) Polyvalent |
| 101099 | Wyeth Pharmaceuticals LLC | 351(a) | CBER | 3 | Antivenin (Micrurus fulvius) |
| 101130 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Antihemophilic Factor (Human) | Koate, Koate-Dvi |
| 101134 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Immune Globulin (Human) | Baygam, Gamastan S/D |
| 101138 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Albumin (Human) | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 |
| 101140 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Plasma Protein Fraction (Human) | Plasmanate |
| 101141 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Rho(D) Immune Globulin (Human) | Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose |
| 101142 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Tetanus Immune Globulin (Human) | Baytet, Hypertet |
| 101144 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Rabies Immune Globulin (Human) | Bayrab, Hyperrab |
| 101146 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Hepatitis B Immune Globulin (Human) | Bayhep B, Hyperhep B S/D |
| 101147 | Grifols Therapeutics LLC | 351(a) | CBER | 1871 | Immune Globulin Intravenous (Human) | Gamimune |
| 101246 | Recordati Rare Diseases, Inc. | 351(a) | CBER | 1899 | Hemin for Injection | Panhematin |
| 101322 | MassBiologics | 351(a) | CBER | 1779 | Tetanus and Diphtheria Toxoids Adsorbed | Tdvax |
| 101377 | Allergy Laboratories, Inc. | 351(a) | CBER | 103 | Insects (Whole Body), Mite Dermatophagoides farinae |
| 101378 | Allergy Laboratories, Inc. | 351(a) | CBER | 103 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus |
| 101379 | Allergy Laboratories, Inc. | 351(a) | CBER | 103 | Pollens - Grasses, Bermuda Grass Cynodon dactylon |
| 101380 | Allergy Laboratories, Inc. | 351(a) | CBER | 103 | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis |
BLA Number | Applicant | BLA Type | Center | Date of First Licensure | Is Biosimilar | Is Interchangeable | License Number | Proper Name | Proprietary Name | Reference Product | Reference Product Proper Name | Reference Product Proprietary Name |
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