Details for New Drug Application (NDA): 022522
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NDA 022522 describes DALIRESP, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DALIRESP profile page.
The generic ingredient in DALIRESP 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.
The generic ingredient in DALIRESP 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 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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