| 64678-012-01 |
64678-012 |
HUMAN PRESCRIPTION DRUG |
Tembexa |
Brincidofovir |
SUSPENSION |
ORAL |
20220420 |
N/A |
NDA |
NDA214460 |
Emergent BioDefense Operations Lansing LLC |
BRINCIDOFOVIR |
10 mg/mL |
65 mL in 1 BOTTLE (64678-012-01) |
| 64678-012-02 |
64678-012 |
HUMAN PRESCRIPTION DRUG |
Tembexa |
Brincidofovir |
SUSPENSION |
ORAL |
20220420 |
N/A |
NDA |
NDA214460 |
Emergent BioDefense Operations Lansing LLC |
BRINCIDOFOVIR |
10 mg/mL |
65 mL in 1 BOTTLE (64678-012-02) |
| 64678-012-03 |
64678-012 |
HUMAN PRESCRIPTION DRUG |
Tembexa |
Brincidofovir |
SUSPENSION |
ORAL |
20250723 |
N/A |
NDA |
NDA214460 |
Emergent BioDefense Operations Lansing LLC |
BRINCIDOFOVIR |
10 mg/mL |
1 BOTTLE in 1 CARTON (64678-012-03) / 45 mL in 1 BOTTLE |
| 64678-012-04 |
64678-012 |
HUMAN PRESCRIPTION DRUG |
Tembexa |
Brincidofovir |
SUSPENSION |
ORAL |
20250723 |
N/A |
NDA |
NDA214460 |
Emergent BioDefense Operations Lansing LLC |
BRINCIDOFOVIR |
10 mg/mL |
1 BOTTLE in 1 CARTON (64678-012-04) / 45 mL in 1 BOTTLE |
| 79622-012-65 |
79622-012 |
HUMAN PRESCRIPTION DRUG |
Tembexa |
Brincidofovir |
SUSPENSION |
ORAL |
20220420 |
N/A |
NDA |
NDA214460 |
Chimerix, Inc. |
BRINCIDOFOVIR |
10 mg/mL |
65 mL in 1 BOTTLE (79622-012-65) |
| 79622-012-70 |
79622-012 |
HUMAN PRESCRIPTION DRUG |
Tembexa |
Brincidofovir |
SUSPENSION |
ORAL |
20220420 |
N/A |
NDA |
NDA214460 |
Chimerix, Inc. |
BRINCIDOFOVIR |
10 mg/mL |
65 mL in 1 BOTTLE (79622-012-70) |