Details for New Drug Application (NDA): 213298
✉ Email this page to a colleague
NDA 213298 describes ROFLUMILAST, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in eleven NDAs. It is available from twelve suppliers. Additional details are available on the ROFLUMILAST profile page.
The generic ingredient in ROFLUMILAST is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
The generic ingredient in ROFLUMILAST is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 213298
| Tradename: | ROFLUMILAST |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | roflumilast |
| Patents: | 0 |
Pharmacology for NDA: 213298
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 213298
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROFLUMILAST | roflumilast | TABLET;ORAL | 213298 | ANDA | Aurobindo Pharma Limited | 59651-275 | 59651-275-30 | 30 TABLET in 1 BOTTLE (59651-275-30) |
| ROFLUMILAST | roflumilast | TABLET;ORAL | 213298 | ANDA | Aurobindo Pharma Limited | 59651-275 | 59651-275-90 | 90 TABLET in 1 BOTTLE (59651-275-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MCG | ||||
| Approval Date: | Apr 17, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
