ROFLUMILAST
ROFLUMILAST is an active ingredient listed in 7 FDA drug label records from 7 manufacturers taken by oral route marketed mainly as human prescription drug products.
About ROFLUMILAST
ROFLUMILAST appears as the active ingredient in 7 FDA drug label records. These products are produced by 7 distinct manufacturers, with the largest catalogues from Amici Pharma Inc., Arcutis Biotherapeutics, Inc., AstraZeneca Pharmaceuticals LP. In this ingredient’s product set, the most common route of administration is oral. Approved labelling for these products most frequently references: indicated treatment, risk copd, exacerbations patients, chronic bronchitis, relief acute, roflumilast tablets, mcg starting, effective therapeutic. Every record below is taken from FDA Structured Product Labelling data; use it to compare brand names, strengths and manufacturers before speaking with a pharmacist.
How it is supplied
| Dosage form | Products | Route | Products |
|---|---|---|---|
| — | — | ORAL | 6 |
| — | — | TOPICAL | 1 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Main manufacturers
| Manufacturer | Products | Marketing type |
|---|---|---|
| Amici Pharma Inc. | 1 | HUMAN PRESCRIPTION DRUG |
| Arcutis Biotherapeutics, Inc. | 1 | HUMAN PRESCRIPTION DRUG |
| AstraZeneca Pharmaceuticals LP | 1 | HUMAN PRESCRIPTION DRUG |
| AvKARE | 1 | HUMAN PRESCRIPTION DRUG |
| Camber Pharmaceuticals, Inc. | 1 | HUMAN PRESCRIPTION DRUG |
| Jubilant Cadista Pharmaceuticals Inc. | 1 | HUMAN PRESCRIPTION DRUG |
FDA drug products containing ROFLUMILAST
| Brand name | Manufacturer | Type | Route | Dosage form |
|---|---|---|---|---|
| Daliresp | AstraZeneca Pharmaceuticals LP | HUMAN PRESCRIPTION DRUG | ORAL | |
| ROFLUMILAST | Solco Healthcare US, LLC. | HUMAN PRESCRIPTION DRUG | ORAL | |
| ROFLUMILAST | Amici Pharma Inc. | HUMAN PRESCRIPTION DRUG | ORAL | |
| Roflumilast | Camber Pharmaceuticals, Inc. | HUMAN PRESCRIPTION DRUG | ORAL | |
| Roflumilast | Jubilant Cadista Pharmaceuticals Inc. | HUMAN PRESCRIPTION DRUG | ORAL | |
| ZORYVE | Arcutis Biotherapeutics, Inc. | HUMAN PRESCRIPTION DRUG | TOPICAL | |
| roflumilast | AvKARE | HUMAN PRESCRIPTION DRUG | ORAL |
Frequently asked questions
How many FDA drug products contain ROFLUMILAST?
7 FDA drug label records list ROFLUMILAST as the active ingredient, supplied by 7 manufacturers. The table below lists the brand names, manufacturers and dosage forms covered by those labels.
Which companies make ROFLUMILAST products?
The manufacturers with the most ROFLUMILAST label records are Amici Pharma Inc., Arcutis Biotherapeutics, Inc., AstraZeneca Pharmaceuticals LP. Generic and brand versions may be produced by different companies.
Is this a substitute for medical advice?
No. This page reproduces FDA labelling data so you can identify a product and its manufacturer. Dosing, interactions and suitability must be confirmed with a prescriber or pharmacist.
This page reproduces FDA Structured Product Labelling data for identification purposes. It is not medical advice and does not recommend, sell or price any medicine.