| 0904-7413-35 |
0904-7413 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20231218 |
N/A |
ANDA |
ANDA214557 |
Major Pharmaceuticals |
VARENICLINE TARTRATE |
.5 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (0904-7413-35) |
| 0904-7414-35 |
0904-7414 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20231218 |
N/A |
ANDA |
ANDA214557 |
Major Pharmaceuticals |
VARENICLINE TARTRATE |
1 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (0904-7414-35) |
| 0904-7415-16 |
0904-7415 |
HUMAN PRESCRIPTION DRUG |
Varenicline |
Varenicline tartrate |
KIT |
|
20231218 |
N/A |
ANDA |
ANDA214557 |
Major Pharmaceuticals |
|
|
1 KIT in 1 CARTON (0904-7415-16) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK |
| 50090-7135-0 |
50090-7135 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20240419 |
N/A |
ANDA |
ANDA214557 |
A-S Medication Solutions |
VARENICLINE TARTRATE |
.5 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (50090-7135-0) |
| 42291-927-56 |
42291-927 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20230914 |
N/A |
ANDA |
ANDA214557 |
AvKARE |
VARENICLINE TARTRATE |
.5 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (42291-927-56) |
| 42291-928-56 |
42291-928 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20230914 |
N/A |
ANDA |
ANDA214557 |
AvKARE |
VARENICLINE TARTRATE |
1 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (42291-928-56) |
| 42291-929-53 |
42291-929 |
HUMAN PRESCRIPTION DRUG |
Varenicline |
Varenicline tartrate |
KIT |
|
20230914 |
N/A |
ANDA |
ANDA214557 |
AvKARE |
|
|
1 KIT in 1 CARTON (42291-929-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK |
| 67877-743-95 |
67877-743 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20230825 |
N/A |
ANDA |
ANDA214557 |
Ascend Laboratories, LLC |
VARENICLINE TARTRATE |
.5 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (67877-743-95) |
| 67877-744-54 |
67877-744 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20230825 |
N/A |
ANDA |
ANDA214557 |
Ascend Laboratories, LLC |
VARENICLINE TARTRATE |
1 mg/1 |
1 BLISTER PACK in 1 CARTON (67877-744-54) / 56 TABLET, FILM COATED in 1 BLISTER PACK |
| 67877-744-95 |
67877-744 |
HUMAN PRESCRIPTION DRUG |
varenicline |
varenicline tartrate |
TABLET, FILM COATED |
ORAL |
20230825 |
N/A |
ANDA |
ANDA214557 |
Ascend Laboratories, LLC |
VARENICLINE TARTRATE |
1 mg/1 |
56 TABLET, FILM COATED in 1 BOTTLE (67877-744-95) |
| 67877-745-54 |
67877-745 |
HUMAN PRESCRIPTION DRUG |
Varenicline |
Varenicline tartrate |
KIT |
|
20230825 |
N/A |
ANDA |
ANDA214557 |
Ascend Laboratories, LLC |
|
|
1 KIT in 1 CARTON (67877-745-54) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK |