59148-053-98 |
59148-053 |
HUMAN PRESCRIPTION DRUG |
Nuedexta |
dextromethorphan hydrobromide and quinidine sulfate |
CAPSULE, GELATIN COATED |
ORAL |
20230103 |
N/A |
NDA |
NDA021879 |
Otsuka America Pharmaceutical, Inc |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
20 mg/1; 10 mg/1 |
4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE |
59148-053-16 |
59148-053 |
HUMAN PRESCRIPTION DRUG |
Nuedexta |
dextromethorphan hydrobromide and quinidine sulfate |
CAPSULE, GELATIN COATED |
ORAL |
20230103 |
N/A |
NDA |
NDA021879 |
Otsuka America Pharmaceutical, Inc |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
20 mg/1; 10 mg/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16) |
64597-301-60 |
64597-301 |
HUMAN PRESCRIPTION DRUG |
NUEDEXTA |
dextromethorphan hydrobromide and quinidine sulfate |
CAPSULE, GELATIN COATED |
ORAL |
20101201 |
N/A |
NDA |
NDA021879 |
Avanir Pharmaceuticals, Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
20 mg/1; 10 mg/1 |
60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60) |
64597-301-13 |
64597-301 |
HUMAN PRESCRIPTION DRUG |
NUEDEXTA |
dextromethorphan hydrobromide and quinidine sulfate |
CAPSULE, GELATIN COATED |
ORAL |
20101201 |
N/A |
NDA |
NDA021879 |
Avanir Pharmaceuticals, Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
20 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE |