Details for New Drug Application (NDA): 208180
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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 208180
Tradename: | ROFLUMILAST |
Applicant: | Micro Labs |
Ingredient: | roflumilast |
Patents: | 0 |
Pharmacology for NDA: 208180
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 208180
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROFLUMILAST | roflumilast | TABLET;ORAL | 208180 | ANDA | Micro Labs Limited | 42571-259 | 42571-259-05 | 500 TABLET in 1 BOTTLE (42571-259-05) |
ROFLUMILAST | roflumilast | TABLET;ORAL | 208180 | ANDA | Micro Labs Limited | 42571-259 | 42571-259-17 | 11 BLISTER PACK in 1 CARTON (42571-259-17) / 10 TABLET in 1 BLISTER PACK (42571-259-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MCG | ||||
Approval Date: | Mar 22, 2019 | 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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