| 84388-005-06 |
84388-005 |
HUMAN PRESCRIPTION DRUG |
Enbumyst |
bumetanide |
SPRAY |
NASAL |
20250912 |
N/A |
NDA |
NDA219500 |
Corstasis USA LLC |
BUMETANIDE |
.5 mg/.1mL |
6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
| 84388-005-12 |
84388-005 |
HUMAN PRESCRIPTION DRUG |
Enbumyst |
bumetanide |
SPRAY |
NASAL |
20250912 |
N/A |
NDA |
NDA219500 |
Corstasis USA LLC |
BUMETANIDE |
.5 mg/.1mL |
12 BLISTER PACK in 1 CARTON (84388-005-12) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
| 49396-0050-2 |
49396-0050 |
HUMAN PRESCRIPTION DRUG |
Enbumyst |
Bumetanide Nasal Spray |
SPRAY |
NASAL |
20250912 |
N/A |
NDA |
NDA219500 |
Renaissance Lakewood LLC |
BUMETANIDE |
.5 mg/mL |
12 BLISTER PACK in 1 CARTON (49396-0050-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
| 49396-0050-6 |
49396-0050 |
HUMAN PRESCRIPTION DRUG |
Enbumyst |
Bumetanide Nasal Spray |
SPRAY |
NASAL |
20250912 |
N/A |
NDA |
NDA219500 |
Renaissance Lakewood LLC |
BUMETANIDE |
.5 mg/mL |
6 BLISTER PACK in 1 CARTON (49396-0050-6) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |