| 82293-040-10 |
82293-040 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
20270430 |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
97 mg/1; 103 mg/1 |
60 TABLET, FILM COATED in 1 BOTTLE (82293-040-10) |
| 82293-040-20 |
82293-040 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
20270430 |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
97 mg/1; 103 mg/1 |
180 TABLET, FILM COATED in 1 BOTTLE (82293-040-20) |
| 82293-040-30 |
82293-040 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
20270430 |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
97 mg/1; 103 mg/1 |
100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-040-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-040-31) |
| 82293-029-10 |
82293-029 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
97 mg/1; 103 mg/1 |
60 TABLET, FILM COATED in 1 BOTTLE (82293-029-10) |
| 82293-029-20 |
82293-029 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
97 mg/1; 103 mg/1 |
180 TABLET, FILM COATED in 1 BOTTLE (82293-029-20) |
| 82293-029-30 |
82293-029 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
97 mg/1; 103 mg/1 |
100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-029-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-029-31) |
| 82293-027-10 |
82293-027 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
24 mg/1; 26 mg/1 |
60 TABLET, FILM COATED in 1 BOTTLE (82293-027-10) |
| 82293-027-20 |
82293-027 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
24 mg/1; 26 mg/1 |
180 TABLET, FILM COATED in 1 BOTTLE (82293-027-20) |
| 82293-027-30 |
82293-027 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
24 mg/1; 26 mg/1 |
100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-027-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-027-31) |
| 82293-028-10 |
82293-028 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
49 mg/1; 51 mg/1 |
60 TABLET, FILM COATED in 1 BOTTLE (82293-028-10) |
| 82293-028-20 |
82293-028 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
49 mg/1; 51 mg/1 |
180 TABLET, FILM COATED in 1 BOTTLE (82293-028-20) |
| 82293-028-30 |
82293-028 |
HUMAN PRESCRIPTION DRUG |
Sacubitril and Valsartan |
Sacubitril and Valsartan |
TABLET, FILM COATED |
ORAL |
20250716 |
N/A |
ANDA |
ANDA213611 |
Novugen Pharma (USA) LLC |
SACUBITRIL; VALSARTAN |
49 mg/1; 51 mg/1 |
100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-028-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-028-31) |