Details for New Drug Application (NDA): 022522
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The generic ingredient in DALIRESP 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 022522
Tradename: | DALIRESP |
Applicant: | Astrazeneca |
Ingredient: | roflumilast |
Patents: | 3 |
Pharmacology for NDA: 022522
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 022522
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DALIRESP | roflumilast | TABLET;ORAL | 022522 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0088 | 0310-0088-28 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK |
DALIRESP | roflumilast | TABLET;ORAL | 022522 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0088 | 0310-0088-39 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) / 2 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MCG | ||||
Approval Date: | Feb 28, 2011 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022522
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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