| 71205-016-10 |
71205-016 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20180402 |
N/A |
ANDA |
ANDA207466 |
Proficient Rx LP |
METAXALONE |
800 mg/1 |
10 TABLET in 1 BOTTLE (71205-016-10) |
| 71205-016-30 |
71205-016 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20180402 |
N/A |
ANDA |
ANDA207466 |
Proficient Rx LP |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE (71205-016-30) |
| 71205-016-60 |
71205-016 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20180402 |
N/A |
ANDA |
ANDA207466 |
Proficient Rx LP |
METAXALONE |
800 mg/1 |
60 TABLET in 1 BOTTLE (71205-016-60) |
| 71205-016-90 |
71205-016 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20180402 |
N/A |
ANDA |
ANDA207466 |
Proficient Rx LP |
METAXALONE |
800 mg/1 |
90 TABLET in 1 BOTTLE (71205-016-90) |
| 68001-485-00 |
68001-485 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20210531 |
N/A |
ANDA |
ANDA207466 |
BluePoint Laboratories |
METAXALONE |
800 mg/1 |
100 TABLET in 1 BOTTLE (68001-485-00) |
| 69097-998-07 |
69097-998 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20230612 |
N/A |
ANDA |
ANDA207466 |
CIPLA USA INC. |
METAXALONE |
400 mg/1 |
100 TABLET in 1 BOTTLE (69097-998-07) |
| 0904-6831-04 |
0904-6831 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20170831 |
N/A |
ANDA |
ANDA207466 |
Major Pharmaceuticals |
METAXALONE |
800 mg/1 |
30 BLISTER PACK in 1 CARTON (0904-6831-04) / 1 TABLET in 1 BLISTER PACK |
| 0904-6831-06 |
0904-6831 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20170831 |
N/A |
ANDA |
ANDA207466 |
Major Pharmaceuticals |
METAXALONE |
800 mg/1 |
50 BLISTER PACK in 1 CARTON (0904-6831-06) / 1 TABLET in 1 BLISTER PACK |
| 72789-028-15 |
72789-028 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20191119 |
N/A |
ANDA |
ANDA207466 |
PD-Rx Pharmaceuticals, Inc. |
METAXALONE |
800 mg/1 |
15 TABLET in 1 BOTTLE, PLASTIC (72789-028-15) |
| 72789-028-30 |
72789-028 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20191111 |
N/A |
ANDA |
ANDA207466 |
PD-Rx Pharmaceuticals, Inc. |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (72789-028-30) |
| 55111-650-01 |
55111-650 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20170831 |
N/A |
ANDA |
ANDA207466 |
Dr. Reddy’s Laboratories Limited |
METAXALONE |
800 mg/1 |
100 TABLET in 1 BOTTLE (55111-650-01) |
| 0276-0508-10 |
0276-0508 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20211101 |
N/A |
ANDA |
ANDA207466 |
Misemer Pharmaceuticals, Inc. |
METAXALONE |
400 mg/1 |
100 TABLET in 1 BOTTLE (0276-0508-10) |
| 50228-323-01 |
50228-323 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20170831 |
N/A |
ANDA |
ANDA207466 |
ScieGen Pharmaceuticals, Inc. |
METAXALONE |
800 mg/1 |
100 TABLET in 1 BOTTLE (50228-323-01) |
| 50228-323-05 |
50228-323 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20170831 |
N/A |
ANDA |
ANDA207466 |
ScieGen Pharmaceuticals, Inc. |
METAXALONE |
800 mg/1 |
500 TABLET in 1 BOTTLE (50228-323-05) |
| 50228-323-30 |
50228-323 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20170831 |
N/A |
ANDA |
ANDA207466 |
ScieGen Pharmaceuticals, Inc. |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE (50228-323-30) |
| 50228-474-10 |
50228-474 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20200430 |
N/A |
ANDA |
ANDA207466 |
ScieGen Pharmaceuticals, Inc. |
METAXALONE |
400 mg/1 |
1000 TABLET in 1 BOTTLE (50228-474-10) |
| 50228-474-30 |
50228-474 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20200430 |
N/A |
ANDA |
ANDA207466 |
ScieGen Pharmaceuticals, Inc. |
METAXALONE |
400 mg/1 |
30 TABLET in 1 BOTTLE (50228-474-30) |
| 80425-0524-1 |
80425-0524 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20250529 |
N/A |
ANDA |
ANDA207466 |
Advanced Rx of Tennessee, LLC |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE (80425-0524-1) |
| 80425-0524-2 |
80425-0524 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20250529 |
N/A |
ANDA |
ANDA207466 |
Advanced Rx of Tennessee, LLC |
METAXALONE |
800 mg/1 |
60 TABLET in 1 BOTTLE (80425-0524-2) |
| 80425-0524-3 |
80425-0524 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20250529 |
N/A |
ANDA |
ANDA207466 |
Advanced Rx of Tennessee, LLC |
METAXALONE |
800 mg/1 |
90 TABLET in 1 BOTTLE (80425-0524-3) |