| 59746-801-70 |
59746-801 |
HUMAN PRESCRIPTION DRUG |
Roflumilast |
roflumilast |
TABLET |
ORAL |
20260202 |
N/A |
ANDA |
ANDA208236 |
Jubilant Cadista Pharmaceuticals Inc. |
ROFLUMILAST |
250 ug/1 |
28 TABLET in 1 BLISTER PACK (59746-801-70) |
| 69292-631-30 |
69292-631 |
HUMAN PRESCRIPTION DRUG |
ROFLUMILAST |
ROFLUMILAST |
TABLET |
ORAL |
20260205 |
N/A |
ANDA |
ANDA208236 |
Amici Pharma Inc. |
ROFLUMILAST |
500 ug/1 |
30 TABLET in 1 BOTTLE (69292-631-30) |
| 69292-631-90 |
69292-631 |
HUMAN PRESCRIPTION DRUG |
ROFLUMILAST |
ROFLUMILAST |
TABLET |
ORAL |
20260205 |
N/A |
ANDA |
ANDA208236 |
Amici Pharma Inc. |
ROFLUMILAST |
500 ug/1 |
90 TABLET in 1 BOTTLE (69292-631-90) |
| 69292-630-20 |
69292-630 |
HUMAN PRESCRIPTION DRUG |
ROFLUMILAST |
ROFLUMILAST |
TABLET |
ORAL |
20260205 |
N/A |
ANDA |
ANDA208236 |
Amici Pharma Inc. |
ROFLUMILAST |
250 ug/1 |
2 BLISTER PACK in 1 CARTON (69292-630-20) / 10 TABLET in 1 BLISTER PACK |
| 69292-630-28 |
69292-630 |
HUMAN PRESCRIPTION DRUG |
ROFLUMILAST |
ROFLUMILAST |
TABLET |
ORAL |
20260205 |
N/A |
ANDA |
ANDA208236 |
Amici Pharma Inc. |
ROFLUMILAST |
250 ug/1 |
2 BLISTER PACK in 1 CARTON (69292-630-28) / 14 TABLET in 1 BLISTER PACK |
| 59746-802-05 |
59746-802 |
HUMAN PRESCRIPTION DRUG |
Roflumilast |
roflumilast |
TABLET |
ORAL |
20260202 |
N/A |
ANDA |
ANDA208236 |
Jubilant Cadista Pharmaceuticals Inc. |
ROFLUMILAST |
500 ug/1 |
500 TABLET in 1 BOTTLE (59746-802-05) |
| 59746-802-30 |
59746-802 |
HUMAN PRESCRIPTION DRUG |
Roflumilast |
roflumilast |
TABLET |
ORAL |
20260202 |
N/A |
ANDA |
ANDA208236 |
Jubilant Cadista Pharmaceuticals Inc. |
ROFLUMILAST |
500 ug/1 |
30 TABLET in 1 BOTTLE (59746-802-30) |
| 59746-802-90 |
59746-802 |
HUMAN PRESCRIPTION DRUG |
Roflumilast |
roflumilast |
TABLET |
ORAL |
20260202 |
N/A |
ANDA |
ANDA208236 |
Jubilant Cadista Pharmaceuticals Inc. |
ROFLUMILAST |
500 ug/1 |
90 TABLET in 1 BOTTLE (59746-802-90) |