| 0527-1435-05 |
0527-1435 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20161122 |
N/A |
ANDA |
ANDA204770 |
Lannett Company, Inc. |
METAXALONE |
800 mg/1 |
500 TABLET in 1 BOTTLE (0527-1435-05) |
| 0527-1435-01 |
0527-1435 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20161122 |
N/A |
ANDA |
ANDA204770 |
Lannett Company, Inc. |
METAXALONE |
800 mg/1 |
100 TABLET in 1 BOTTLE (0527-1435-01) |
| 70518-0771-1 |
70518-0771 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20190114 |
N/A |
ANDA |
ANDA204770 |
REMEDYREPACK INC. |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (70518-0771-1) |
| 70518-0771-0 |
70518-0771 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20171009 |
N/A |
ANDA |
ANDA204770 |
REMEDYREPACK INC. |
METAXALONE |
800 mg/1 |
90 TABLET in 1 BOTTLE, PLASTIC (70518-0771-0) |
| 70518-0771-4 |
70518-0771 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20240626 |
N/A |
ANDA |
ANDA204770 |
REMEDYREPACK INC. |
METAXALONE |
800 mg/1 |
120 TABLET in 1 BOTTLE, PLASTIC (70518-0771-4) |
| 71335-0958-1 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20180927 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE (71335-0958-1) |
| 71335-0958-4 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20190401 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
120 TABLET in 1 BOTTLE (71335-0958-4) |
| 71335-0958-5 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20210729 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
15 TABLET in 1 BOTTLE (71335-0958-5) |
| 71335-0958-6 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20210125 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
10 TABLET in 1 BOTTLE (71335-0958-6) |
| 71335-0958-7 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20190312 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
60 TABLET in 1 BOTTLE (71335-0958-7) |
| 71335-0958-8 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20211228 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
16 TABLET in 1 BOTTLE (71335-0958-8) |
| 71335-0958-9 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20211228 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
84 TABLET in 1 BOTTLE (71335-0958-9) |
| 71335-0958-2 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20190611 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
20 TABLET in 1 BOTTLE (71335-0958-2) |
| 71335-0958-3 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20190321 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
90 TABLET in 1 BOTTLE (71335-0958-3) |
| 71335-0958-0 |
71335-0958 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20200508 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
100 TABLET in 1 BOTTLE (71335-0958-0) |
| 63629-2097-1 |
63629-2097 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20161122 |
N/A |
ANDA |
ANDA204770 |
Bryant Ranch Prepack |
METAXALONE |
800 mg/1 |
100 TABLET in 1 BOTTLE (63629-2097-1) |
| 85509-1435-9 |
85509-1435 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20251016 |
N/A |
ANDA |
ANDA204770 |
PHOENIX RX LLC |
METAXALONE |
800 mg/1 |
90 TABLET in 1 BOTTLE (85509-1435-9) |
| 85509-1435-1 |
85509-1435 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20251016 |
N/A |
ANDA |
ANDA204770 |
PHOENIX RX LLC |
METAXALONE |
800 mg/1 |
120 TABLET in 1 BOTTLE (85509-1435-1) |
| 85509-1435-3 |
85509-1435 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20251016 |
N/A |
ANDA |
ANDA204770 |
PHOENIX RX LLC |
METAXALONE |
800 mg/1 |
30 TABLET in 1 BOTTLE (85509-1435-3) |
| 85509-1435-6 |
85509-1435 |
HUMAN PRESCRIPTION DRUG |
Metaxalone |
Metaxalone |
TABLET |
ORAL |
20251016 |
N/A |
ANDA |
ANDA204770 |
PHOENIX RX LLC |
METAXALONE |
800 mg/1 |
60 TABLET in 1 BOTTLE (85509-1435-6) |