Suppliers and packages for generic ingredient: ROFLUMILAST
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ROFLUMILAST
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-115-60 | 1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE | 2024-07-09 |
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-115-96 | 6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05) | 2024-07-09 |
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-130-60 | 1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE | 2022-07-29 |
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-130-96 | 6 TUBE in 1 CARTON (80610-130-96) / 5 g in 1 TUBE (80610-130-05) | 2022-07-29 |
| Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242 | NDA | Arcutis Biotherapeutics, Inc. | 80610-430-60 | 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN | 2023-12-15 |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0088-28 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK | 2015-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
