65597-114-07 |
65597-114 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20100731 |
20240831 |
NDA |
NDA200175 |
Daiichi Sankyo, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
7 TABLET, FILM COATED in 1 BOTTLE (65597-114-07) |
65597-114-10 |
65597-114 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20100731 |
20240831 |
NDA |
NDA200175 |
Daiichi Sankyo, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
10 BLISTER PACK in 1 BOX (65597-114-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
65597-114-30 |
65597-114 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20100731 |
20240831 |
NDA |
NDA200175 |
Daiichi Sankyo, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (65597-114-30) |
65597-114-70 |
65597-114 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20100731 |
20240831 |
NDA |
NDA200175 |
Daiichi Sankyo, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
7 TABLET, FILM COATED in 1 BLISTER PACK (65597-114-70) |
65597-114-90 |
65597-114 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20100731 |
20240831 |
NDA |
NDA200175 |
Daiichi Sankyo, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
90 TABLET, FILM COATED in 1 BOTTLE (65597-114-90) |
0713-0874-30 |
0713-0874 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20220901 |
N/A |
NDA |
NDA200175 |
Cosette Pharmaceuticals, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0713-0874-30) |
0713-0875-30 |
0713-0875 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20220901 |
N/A |
NDA |
NDA200175 |
Cosette Pharmaceuticals, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 40 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0713-0875-30) |
0713-0876-30 |
0713-0876 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20220901 |
N/A |
NDA |
NDA200175 |
Cosette Pharmaceuticals, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 25 mg/1; 40 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0713-0876-30) |
0713-0877-30 |
0713-0877 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20220901 |
N/A |
NDA |
NDA200175 |
Cosette Pharmaceuticals, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
10 mg/1; 12.5 mg/1; 40 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0713-0877-30) |
0713-0878-30 |
0713-0878 |
HUMAN PRESCRIPTION DRUG |
Tribenzor |
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20220901 |
N/A |
NDA |
NDA200175 |
Cosette Pharmaceuticals, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
10 mg/1; 25 mg/1; 40 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0713-0878-30) |
57664-796-83 |
57664-796 |
HUMAN PRESCRIPTION DRUG |
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide |
olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20161026 |
20240731 |
NDA AUTHORIZED GENERIC |
NDA200175 |
Sun Pharmaceutical Industries, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-796-83) |
57664-796-99 |
57664-796 |
HUMAN PRESCRIPTION DRUG |
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide |
olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide |
TABLET, FILM COATED |
ORAL |
20161026 |
20240731 |
NDA AUTHORIZED GENERIC |
NDA200175 |
Sun Pharmaceutical Industries, Inc. |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
5 mg/1; 12.5 mg/1; 20 mg/1 |
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-796-99) |