81092-1120-1 |
81092-1120 |
HUMAN PRESCRIPTION DRUG |
IGALMI |
DEXMEDETOMIDINE |
FILM |
SUBLINGUAL |
20220701 |
N/A |
NDA |
NDA215390 |
BioXcel Therapeutics, Inc. |
DEXMEDETOMIDINE |
120 ug/1 |
10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0) |
81092-1120-3 |
81092-1120 |
HUMAN PRESCRIPTION DRUG |
IGALMI |
DEXMEDETOMIDINE |
FILM |
SUBLINGUAL |
20240701 |
N/A |
NDA |
NDA215390 |
BioXcel Therapeutics, Inc. |
DEXMEDETOMIDINE |
120 ug/1 |
30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0) |
81092-1180-1 |
81092-1180 |
HUMAN PRESCRIPTION DRUG |
IGALMI |
DEXMEDETOMIDINE |
FILM |
SUBLINGUAL |
20220701 |
N/A |
NDA |
NDA215390 |
BioXcel Therapeutics, Inc. |
DEXMEDETOMIDINE |
180 ug/1 |
10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0) |
81092-1180-3 |
81092-1180 |
HUMAN PRESCRIPTION DRUG |
IGALMI |
DEXMEDETOMIDINE |
FILM |
SUBLINGUAL |
20240701 |
N/A |
NDA |
NDA215390 |
BioXcel Therapeutics, Inc. |
DEXMEDETOMIDINE |
180 ug/1 |
30 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0) |