| 80610-105-60 |
80610-105 |
HUMAN PRESCRIPTION DRUG |
ZORYVE |
roflumilast |
CREAM |
TOPICAL |
20251004 |
N/A |
NDA |
NDA215985 |
Arcutis Biotherapeutics, Inc. |
ROFLUMILAST |
.5 mg/g |
1 TUBE in 1 CARTON (80610-105-60) / 60 g in 1 TUBE |
| 80610-105-96 |
80610-105 |
HUMAN PRESCRIPTION DRUG |
ZORYVE |
roflumilast |
CREAM |
TOPICAL |
20251004 |
N/A |
NDA |
NDA215985 |
Arcutis Biotherapeutics, Inc. |
ROFLUMILAST |
.5 mg/g |
6 TUBE in 1 CARTON (80610-105-96) / 5 g in 1 TUBE (80610-105-05) |
| 80610-130-60 |
80610-130 |
HUMAN PRESCRIPTION DRUG |
ZORYVE |
roflumilast |
CREAM |
TOPICAL |
20220729 |
N/A |
NDA |
NDA215985 |
Arcutis Biotherapeutics, Inc. |
ROFLUMILAST |
3 mg/g |
1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE |
| 80610-130-96 |
80610-130 |
HUMAN PRESCRIPTION DRUG |
ZORYVE |
roflumilast |
CREAM |
TOPICAL |
20220729 |
N/A |
NDA |
NDA215985 |
Arcutis Biotherapeutics, Inc. |
ROFLUMILAST |
3 mg/g |
6 TUBE in 1 CARTON (80610-130-96) / 5 g in 1 TUBE (80610-130-05) |
| 80610-115-60 |
80610-115 |
HUMAN PRESCRIPTION DRUG |
ZORYVE |
roflumilast |
CREAM |
TOPICAL |
20240709 |
N/A |
NDA |
NDA215985 |
Arcutis Biotherapeutics, Inc. |
ROFLUMILAST |
1.5 mg/g |
1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE |
| 80610-115-96 |
80610-115 |
HUMAN PRESCRIPTION DRUG |
ZORYVE |
roflumilast |
CREAM |
TOPICAL |
20240709 |
N/A |
NDA |
NDA215985 |
Arcutis Biotherapeutics, Inc. |
ROFLUMILAST |
1.5 mg/g |
6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05) |