| 0615-8466-05 |
0615-8466 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20230508 |
N/A |
ANDA |
ANDA209102 |
NCS HealthCare of KY, LLC dba Vangard Labs |
BACLOFEN |
10 mg/1 |
15 TABLET in 1 BLISTER PACK (0615-8466-05) |
| 0615-8466-39 |
0615-8466 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20230508 |
N/A |
ANDA |
ANDA209102 |
NCS HealthCare of KY, LLC dba Vangard Labs |
BACLOFEN |
10 mg/1 |
30 TABLET in 1 BLISTER PACK (0615-8466-39) |
| 72789-480-01 |
72789-480 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250121 |
N/A |
ANDA |
ANDA209102 |
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
20 mg/1 |
100 TABLET in 1 BOTTLE, PLASTIC (72789-480-01) |
| 72789-480-90 |
72789-480 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250707 |
N/A |
ANDA |
ANDA209102 |
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
20 mg/1 |
90 TABLET in 1 BOTTLE, PLASTIC (72789-480-90) |
| 72789-480-95 |
72789-480 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250121 |
N/A |
ANDA |
ANDA209102 |
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
20 mg/1 |
1000 TABLET in 1 BOTTLE, PLASTIC (72789-480-95) |
| 76420-357-00 |
76420-357 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
10 mg/1 |
1000 TABLET in 1 BOTTLE (76420-357-00) |
| 76420-357-01 |
76420-357 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
10 mg/1 |
100 TABLET in 1 BOTTLE (76420-357-01) |
| 76420-357-05 |
76420-357 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
10 mg/1 |
500 TABLET in 1 BOTTLE (76420-357-05) |
| 76420-357-12 |
76420-357 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250813 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
10 mg/1 |
120 TABLET in 1 BOTTLE (76420-357-12) |
| 76420-357-30 |
76420-357 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
10 mg/1 |
30 TABLET in 1 BOTTLE (76420-357-30) |
| 72888-010-00 |
72888-010 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20180401 |
N/A |
ANDA |
ANDA209102 |
Advagen Pharma Limited |
BACLOFEN |
10 mg/1 |
1000 TABLET in 1 BOTTLE (72888-010-00) |
| 72888-010-01 |
72888-010 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20180401 |
N/A |
ANDA |
ANDA209102 |
Advagen Pharma Limited |
BACLOFEN |
10 mg/1 |
100 TABLET in 1 BOTTLE (72888-010-01) |
| 72888-010-05 |
72888-010 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20180401 |
N/A |
ANDA |
ANDA209102 |
Advagen Pharma Limited |
BACLOFEN |
10 mg/1 |
500 TABLET in 1 BOTTLE (72888-010-05) |
| 72789-478-01 |
72789-478 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250121 |
N/A |
ANDA |
ANDA209102 |
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
5 mg/1 |
100 TABLET in 1 BOTTLE, PLASTIC (72789-478-01) |
| 72789-478-30 |
72789-478 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250828 |
N/A |
ANDA |
ANDA209102 |
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
5 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (72789-478-30) |
| 76420-359-00 |
76420-359 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
20 mg/1 |
1000 TABLET in 1 BOTTLE (76420-359-00) |
| 76420-359-01 |
76420-359 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
20 mg/1 |
100 TABLET in 1 BOTTLE (76420-359-01) |
| 76420-359-05 |
76420-359 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
20 mg/1 |
500 TABLET in 1 BOTTLE (76420-359-05) |
| 76420-359-30 |
76420-359 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
20 mg/1 |
30 TABLET in 1 BOTTLE (76420-359-30) |
| 76420-359-60 |
76420-359 |
HUMAN PRESCRIPTION DRUG |
BACLOFEN |
BACLOFEN |
TABLET |
ORAL |
20250522 |
N/A |
ANDA |
ANDA209102 |
Asclemed USA, Inc. |
BACLOFEN |
20 mg/1 |
60 TABLET in 1 BOTTLE (76420-359-60) |