Details for New Drug Application (NDA): 208247
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The generic ingredient in ROFLUMILAST is roflumilast. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 208247
Tradename: | ROFLUMILAST |
Applicant: | Strides Pharma |
Ingredient: | roflumilast |
Patents: | 0 |
Pharmacology for NDA: 208247
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 208247
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROFLUMILAST | roflumilast | TABLET;ORAL | 208247 | ANDA | Strides Pharma Science Limited | 64380-786 | 64380-786-01 | 30 TABLET in 1 BOTTLE (64380-786-01) |
ROFLUMILAST | roflumilast | TABLET;ORAL | 208247 | ANDA | Strides Pharma Science Limited | 64380-786 | 64380-786-05 | 90 TABLET in 1 BOTTLE (64380-786-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MCG | ||||
Approval Date: | Mar 30, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MCG | ||||
Approval Date: | Jun 20, 2023 | TE: | AB | RLD: | No |
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