| 72769-111-02 |
72769-111 |
HUMAN PRESCRIPTION DRUG |
Orladeyo |
Berotralstat hydrochloride |
PELLET |
ORAL |
20201212 |
N/A |
NDA |
NDA219776 |
BioCryst Pharmaceuticals Inc. |
BEROTRALSTAT HYDROCHLORIDE |
72 mg/1 |
4 DOSE PACK in 1 CARTON (72769-111-02) / 7 PACKET in 1 DOSE PACK / 12 PELLET in 1 PACKET |
| 72769-112-02 |
72769-112 |
HUMAN PRESCRIPTION DRUG |
Orladeyo |
Berotralstat hydrochloride |
PELLET |
ORAL |
20201212 |
N/A |
NDA |
NDA219776 |
BioCryst Pharmaceuticals Inc. |
BEROTRALSTAT HYDROCHLORIDE |
96 mg/1 |
4 DOSE PACK in 1 CARTON (72769-112-02) / 7 PACKET in 1 DOSE PACK / 16 PELLET in 1 PACKET |
| 72769-113-02 |
72769-113 |
HUMAN PRESCRIPTION DRUG |
Orladeyo |
Berotralstat hydrochloride |
PELLET |
ORAL |
20201212 |
N/A |
NDA |
NDA219776 |
BioCryst Pharmaceuticals Inc. |
BEROTRALSTAT HYDROCHLORIDE |
108 mg/1 |
4 DOSE PACK in 1 CARTON (72769-113-02) / 7 PACKET in 1 DOSE PACK / 18 PELLET in 1 PACKET |
| 72769-114-02 |
72769-114 |
HUMAN PRESCRIPTION DRUG |
Orladeyo |
Berotralstat hydrochloride |
PELLET |
ORAL |
20201212 |
N/A |
NDA |
NDA219776 |
BioCryst Pharmaceuticals Inc. |
BEROTRALSTAT HYDROCHLORIDE |
132 mg/1 |
4 DOSE PACK in 1 CARTON (72769-114-02) / 7 PACKET in 1 DOSE PACK / 22 PELLET in 1 PACKET |