Details for New Drug Application (NDA): 200796
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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: | ⤷ Sign Up | Patent Expiration: | May 22, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
Patent: | ⤷ Sign Up | 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 | 200796-002 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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