Novo Nordisk A/S (NVO)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761156 - NOVO NORDISK INC | |||||||
| SOGROYA | SOMAPACITAN-BECO | SOLUTION;SUBCUTANEOUS | 10MG/1.5ML | Prescription | |||
| NDA215842 - NOVO | |||||||
| RIVFLOZA | NEDOSIRAN SODIUM | SOLUTION;INJECTION | EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) | Prescription | |||
| RIVFLOZA | NEDOSIRAN SODIUM | SOLUTION;INJECTION | EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) | Prescription | |||
| RIVFLOZA | NEDOSIRAN SODIUM | SOLUTION;INJECTION | EQ 160MG BASE/ML (EQ 160MG BASE/ML) | Prescription | |||
| NDA215256 - NOVO | |||||||
| WEGOVY | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 2.4MG/0.75ML (2.4MG/0.75ML) | Prescription | |||
| WEGOVY | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 1.7MG/0.75ML (1.7MG/0.75ML) | Prescription | |||
| WEGOVY | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 0.25MG/0.5ML (0.25MG/0.5ML) | Prescription | |||
| WEGOVY | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 0.5MG/0.5ML (0.5MG/0.5ML) | Prescription | |||
| WEGOVY | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 1MG/0.5ML (1MG/0.5ML) | Prescription | |||
| NDA213182 - NOVO NORDISK INC | |||||||
| RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 7MG | Prescription | |||
| RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 3MG | Prescription | |||
| NDA213051 - NOVO | |||||||
| RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 7MG | Prescription | |||
| RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 14MG | Prescription | |||
| RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 3MG | Prescription | |||
| NDA209637 - NOVO | |||||||
| OZEMPIC | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 2MG/1.5ML (1.34MG/ML) | Prescription | |||
| OZEMPIC | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 4MG/3ML (1.34MG/ML) | Prescription | |||
| OZEMPIC | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 8MG/3ML (2.68MG/ML) | Prescription | |||
| OZEMPIC | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 2MG/3ML (0.68MG/ML) | Prescription | |||
| BLA208751 - NOVO | |||||||
| FIASP | INSULIN ASPART | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | Prescription | |||
| FIASP FLEXTOUCH | INSULIN ASPART | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| FIASP PENFILL | INSULIN ASPART | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| BLA208583 - NOVO | |||||||
| XULTOPHY 100/3.6 | INSULIN DEGLUDEC; LIRAGLUTIDE | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) | Prescription | |||
| NDA206321 - NOVO | |||||||
| SAXENDA | LIRAGLUTIDE | SOLUTION;SUBCUTANEOUS | 18MG/3ML (6MG/ML) | Prescription | |||
| NDA205598 - NOVO | |||||||
| MACRILEN | MACIMORELIN ACETATE | FOR SOLUTION;ORAL | EQ 60MG BASE/POUCH | Discontinued | |||
| BLA203314 - NOVO | |||||||
| TRESIBA | INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| TRESIBA | INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 600 UNITS/3ML (200 UNITS/ML) | Prescription | |||
| TRESIBA | INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | Prescription | |||
| BLA203313 - NOVO | |||||||
| RYZODEG 70/30 | INSULIN ASPART; INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) | Discontinued | |||
| ANDA075370 - KRKA DD NOVO MESTO | |||||||
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 2.5MG | Discontinued | |||
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 5MG | Discontinued | |||
| ANDA075369 - KRKA DD NOVO MESTO | |||||||
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 10MG | Discontinued | |||
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 20MG | Discontinued | |||
| ANDA040312 - NOVO NORDISK INC | |||||||
| INNOFEM | ESTRADIOL | TABLET;ORAL | 1MG | Discontinued | |||
| INNOFEM | ESTRADIOL | TABLET;ORAL | 2MG | Discontinued | |||
| INNOFEM | ESTRADIOL | TABLET;ORAL | 0.5MG | Discontinued | |||
| NDA022386 - NOVO NORDISK INC | |||||||
| PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE | TABLET;ORAL | 500MG;1MG | Discontinued | |||
| PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE | TABLET;ORAL | 500MG;2MG | Discontinued | |||
| NDA022341 - NOVO NORDISK INC | |||||||
| VICTOZA | LIRAGLUTIDE | SOLUTION;SUBCUTANEOUS | 18MG/3ML (6MG/ML) | Prescription | |||
| NDA022001 - NOVO NORDISK INC | |||||||
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | TABLET; ORAL | 1MG/0.5MG | Prescription | |||
| BLA021878 - NOVO NORDISK | |||||||
| LEVEMIR | INSULIN DETEMIR | INJECTABLE; INJECTION | 100 UNITS/ML | Prescription | |||
| BLA021810 - NOVO NORDISK INC | |||||||
| NOVOLOG MIX 50/50 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 50 UNITS/ML;50 UNITS/ML | Discontinued | |||
| BLA021536 - NOVO NORDISK INC | |||||||
| LEVEMIR FLEXPEN | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Discontinued | |||
| LEVEMIR INNOLET | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Discontinued | |||
| LEVEMIR PENFILL | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Discontinued | |||
| LEVEMIR | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | Prescription | |||
| LEVEMIR FLEXTOUCH | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| BLA021172 - NOVO NORDISK INC | |||||||
| NOVOLOG MIX 70/30 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML) | Prescription | |||
| NOVOLOG MIX 70/30 PENFILL | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | Discontinued | |||
| NOVOLOG MIX 70/30 PENFILL | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | Discontinued | |||
| NOVOLOG MIX 70/30 FLEXPEN | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | Prescription | |||
| BLA021148 - NOVO NORDISK INC | |||||||
| NORDITROPIN NORDIFLEX | SOMATROPIN | INJECTABLE;INJECTION | 5MG/1.5ML | Discontinued | |||
| NORDITROPIN NORDIFLEX | SOMATROPIN | INJECTABLE;INJECTION | 10MG/1.5ML | Discontinued | |||
| NORDITROPIN NORDIFLEX | SOMATROPIN | INJECTABLE;INJECTION | 15MG/1.5ML | Discontinued | |||
| NORDITROPIN FLEXPRO | SOMATROPIN | INJECTABLE;INJECTION | 5MG/1.5ML | Prescription | |||
| NORDITROPIN FLEXPRO | SOMATROPIN | INJECTABLE;INJECTION | 10MG/1.5ML | Prescription | |||
| NORDITROPIN FLEXPRO | SOMATROPIN | INJECTABLE;INJECTION | 15MG/1.5ML | Prescription | |||
| NORDITROPIN FLEXPRO | SOMATROPIN | INJECTABLE;INJECTION | 30MG/3ML | Prescription | |||
| NORDITROPIN | SOMATROPIN | INJECTABLE;INJECTION | 10MG/1.5ML | Discontinued | |||
| NORDITROPIN | SOMATROPIN | INJECTABLE;INJECTION | 15MG/1.5ML | Discontinued | |||
| NORDITROPIN NORDIFLEX | SOMATROPIN | INJECTABLE;INJECTION | 30MG/3ML | Discontinued | |||
| NORDITROPIN | SOMATROPIN | INJECTABLE;INJECTION | 5MG/1.5ML | Discontinued | |||
| NDA021103 - NOVO NORDISK | |||||||
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | TABLET; ORAL | 1MG/0.5MG | Discontinued | |||
| BLA020986 - NOVO NORDISK INC | |||||||
| NOVOLOG | INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | Prescription | |||
| NOVOLOG PENFILL | INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| NOVOLOG FLEXPEN | INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| NOVOLOG FLEXTOUCH | INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Discontinued | |||
| NOVOLOG INNOLET | INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Discontinued | |||
| NDA020918 - NOVO NORDISK | |||||||
| GLUCAGEN | GLUCAGON HYDROCHLORIDE | POWDER;INTRAMUSCULAR, INTRAVENOUS | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GLUCAGEN | GLUCAGON HYDROCHLORIDE | POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020908 - NOVO NORDISK INC | |||||||
| VAGIFEM | ESTRADIOL | TABLET;VAGINAL | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VAGIFEM | ESTRADIOL | TABLET;VAGINAL | 10MCG | Prescription | |||
| BLA019991 - NOVO NORDISK INC | |||||||
| NOVOLIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 30 UNITS/ML;70 UNITS/ML | Over-the-counter | |||
| BLA019959 - NOVO NORDISK INC | |||||||
| NOVOLIN N | INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | Over-the-counter | |||
| BLA019938 - NOVO NORDISK INC | |||||||
| NOVOLIN R | INSULIN RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | Over-the-counter | |||
| NDA018385 - NOVO NORDISK INC | |||||||
| ULTRALENTE | INSULIN ZINC SUSP EXTENDED PURIFIED BEEF | INJECTABLE;INJECTION | 100 UNITS/ML | Discontinued | |||