Details for New Drug Application (NDA): 202331
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NDA 202331 describes EDARBYCLOR, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the EDARBYCLOR profile page.
The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
Summary for 202331
| Tradename: | EDARBYCLOR |
| Applicant: | Azurity |
| Ingredient: | azilsartan kamedoxomil; chlorthalidone |
| Patents: | 5 |
Pharmacology for NDA: 202331
| Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
| Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Suppliers and Packaging for NDA: 202331
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 60631-412 | 60631-412-30 | 30 TABLET in 1 BOTTLE (60631-412-30) |
| EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 60631-425 | 60631-425-30 | 30 TABLET in 1 BOTTLE (60631-425-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG MEDOXOMIL;12.5MG | ||||
| Approval Date: | Dec 20, 2011 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 22, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 202331
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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