| 0904-6374-61 |
0904-6374 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20141001 |
N/A |
ANDA |
ANDA090429 |
Major Pharmaceuticals |
ROPINIROLE HYDROCHLORIDE |
1 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-6374-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 46708-032-31 |
46708-032 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
1 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-032-31) |
| 46708-033-31 |
46708-033 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
2 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-033-31) |
| 46708-034-31 |
46708-034 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
3 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-034-31) |
| 46708-035-31 |
46708-035 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
4 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-035-31) |
| 46708-036-31 |
46708-036 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
5 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-036-31) |
| 0904-6373-61 |
0904-6373 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20141001 |
N/A |
ANDA |
ANDA090429 |
Major Pharmaceuticals |
ROPINIROLE HYDROCHLORIDE |
.25 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-6373-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 46708-031-31 |
46708-031 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
.5 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-031-31) |
| 46708-030-31 |
46708-030 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20130912 |
N/A |
ANDA |
ANDA090429 |
Alembic Pharmaceuticals Limited |
ROPINIROLE HYDROCHLORIDE |
.25 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (46708-030-31) |
| 55154-7888-0 |
55154-7888 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20141001 |
N/A |
ANDA |
ANDA090429 |
Cardinal Health 107, LLC |
ROPINIROLE HYDROCHLORIDE |
.25 mg/1 |
10 BLISTER PACK in 1 BAG (55154-7888-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 55154-7633-0 |
55154-7633 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20141001 |
N/A |
ANDA |
ANDA090429 |
Cardinal Health 107, LLC |
ROPINIROLE HYDROCHLORIDE |
1 mg/1 |
10 BLISTER PACK in 1 BAG (55154-7633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 67046-1489-3 |
67046-1489 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20250129 |
N/A |
ANDA |
ANDA090429 |
Coupler LLC |
ROPINIROLE HYDROCHLORIDE |
2 mg/1 |
30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1489-3) |
| 67046-1490-3 |
67046-1490 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE |
ROPINIROLE |
TABLET, FILM COATED |
ORAL |
20250129 |
N/A |
ANDA |
ANDA090429 |
Coupler LLC |
ROPINIROLE HYDROCHLORIDE |
3 mg/1 |
30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1490-3) |
| 0615-8189-39 |
0615-8189 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20180306 |
N/A |
ANDA |
ANDA090429 |
NCS HealthCare of KY, LLC dba Vangard Labs |
ROPINIROLE HYDROCHLORIDE |
.5 mg/1 |
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8189-39) |
| 0615-8188-39 |
0615-8188 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20180305 |
N/A |
ANDA |
ANDA090429 |
NCS HealthCare of KY, LLC dba Vangard Labs |
ROPINIROLE HYDROCHLORIDE |
.25 mg/1 |
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8188-39) |
| 0615-8190-39 |
0615-8190 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20180307 |
N/A |
ANDA |
ANDA090429 |
NCS HealthCare of KY, LLC dba Vangard Labs |
ROPINIROLE HYDROCHLORIDE |
1 mg/1 |
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8190-39) |
| 0615-8191-39 |
0615-8191 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20180305 |
N/A |
ANDA |
ANDA090429 |
NCS HealthCare of KY, LLC dba Vangard Labs |
ROPINIROLE HYDROCHLORIDE |
2 mg/1 |
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8191-39) |
| 71335-0727-1 |
71335-0727 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20190215 |
N/A |
ANDA |
ANDA090429 |
Bryant Ranch Prepack |
ROPINIROLE HYDROCHLORIDE |
.5 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71335-0727-1) |
| 71335-0727-5 |
71335-0727 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20241007 |
N/A |
ANDA |
ANDA090429 |
Bryant Ranch Prepack |
ROPINIROLE HYDROCHLORIDE |
.5 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (71335-0727-5) |
| 71335-0727-2 |
71335-0727 |
HUMAN PRESCRIPTION DRUG |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20180309 |
N/A |
ANDA |
ANDA090429 |
Bryant Ranch Prepack |
ROPINIROLE HYDROCHLORIDE |
.5 mg/1 |
60 TABLET, FILM COATED in 1 BOTTLE (71335-0727-2) |