Roflumilast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Roflumilast.
| Product ID | 13668-476_eb69beeb-c1ba-38f1-e053-2995a90ab8d3 |
| NDC | 13668-476 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Roflumilast |
| Generic Name | Roflumilast |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-10-19 |
| Marketing Category | ANDA / |
| Application Number | ANDA208272 |
| Labeler Name | Torrent Pharmaceuticals Limited |
| Substance Name | ROFLUMILAST |
| Active Ingredient Strength | 500 ug/1 |
| Pharm Classes | Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-10-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208272 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-08-06 |
| Marketing End Date | 2018-08-07 |
| Marketing Category | ANDA |
| Application Number | ANDA208272 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-08-06 |
| Marketing End Date | 2018-08-07 |
| Marketing Category | ANDA |
| Application Number | ANDA208272 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-08-06 |
| Marketing End Date | 2018-08-07 |
| Marketing Category | ANDA |
| Application Number | ANDA208272 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-08-06 |
| Marketing End Date | 2018-08-07 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-1905 | Roflumilast | Roflumilast |
| 13668-476 | Roflumilast | Roflumilast |
| 31722-623 | Roflumilast | Roflumilast |
| 42571-259 | ROFLUMILAST | Roflumilast |
| 43547-005 | ROFLUMILAST | roflumilast |
| 64380-786 | roflumilast | ROFLUMILAST |
| 68382-969 | Roflumilast | Roflumilast |
| 70771-1674 | Roflumilast | Roflumilast |
| 72205-200 | Roflumilast | Roflumilast |
| 72205-201 | Roflumilast | Roflumilast |
| 80610-130 | roflumilast | roflumilast |
| 0310-0088 | Daliresp | roflumilast |
| 0310-0095 | Daliresp | roflumilast |
| 55154-4625 | Daliresp | roflumilast |