Details for New Drug Application (NDA): 200796
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NDA 200796 describes EDARBI, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the EDARBI profile page.
The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.
The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.
Summary for 200796
| Tradename: | EDARBI |
| Applicant: | Azurity |
| Ingredient: | azilsartan kamedoxomil |
| Patents: | 3 |
Pharmacology for NDA: 200796
| Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 200796
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796 | NDA | Azurity Pharmaceuticals, Inc. | 60631-040 | 60631-040-30 | 30 TABLET in 1 BOTTLE (60631-040-30) |
| EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796 | NDA | Azurity Pharmaceuticals, Inc. | 60631-040 | 60631-040-77 | 7 TABLET in 1 BOTTLE (60631-040-77) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG MEDOXOMIL | ||||
| Approval Date: | Feb 25, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 7,157,584 | Patent Expiration: | May 22, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 7,572,920 | Patent Expiration: | Jan 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
| Patent: | 9,066,936 | Patent Expiration: | Mar 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 200796
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | 5,583,141 | ⤷ Subscribe |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | 5,736,555 | ⤷ Subscribe |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | 5,583,141 | ⤷ Subscribe |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | 5,958,961 | ⤷ Subscribe |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | 5,736,555 | ⤷ Subscribe |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | 5,958,961 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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