Details for New Drug Application (NDA): 208303
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NDA 208303 describes ROFLUMILAST, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Micro Labs, MSN, Pharmobedient, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in eleven NDAs. It is available from fourteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 208303
| Tradename: | ROFLUMILAST |
| Applicant: | Zydus Pharms |
| Ingredient: | roflumilast |
| Patents: | 0 |
Pharmacology for NDA: 208303
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 208303
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROFLUMILAST | roflumilast | TABLET;ORAL | 208303 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-624 | 68382-624-31 | 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK |
| ROFLUMILAST | roflumilast | TABLET;ORAL | 208303 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-624 | 68382-624-83 | 2 BLISTER PACK in 1 CARTON (68382-624-83) / 10 TABLET in 1 BLISTER PACK (68382-624-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MCG | ||||
| Approval Date: | Feb 10, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MCG | ||||
| Approval Date: | Apr 18, 2023 | TE: | AB | RLD: | No | ||||
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