Details for New Drug Application (NDA): 219423
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NDA 219423 describes WIDAPLIK, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the WIDAPLIK profile page.
The generic ingredient in WIDAPLIK is amlodipine besylate; indapamide; telmisartan. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; indapamide; telmisartan profile page.
The generic ingredient in WIDAPLIK is amlodipine besylate; indapamide; telmisartan. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; indapamide; telmisartan profile page.
Summary for 219423
| Tradename: | WIDAPLIK |
| Applicant: | Azurity |
| Ingredient: | amlodipine besylate; indapamide; telmisartan |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219423
Generic Entry Date for 219423*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 219423
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 219423
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WIDAPLIK | amlodipine besylate; indapamide; telmisartan | TABLET;ORAL | 219423 | NDA | Azurity Pharmaceuticals, Inc. | 24338-001 | 24338-001-30 | 30 TABLET in 1 BOTTLE (24338-001-30) |
| WIDAPLIK | amlodipine besylate; indapamide; telmisartan | TABLET;ORAL | 219423 | NDA | Azurity Pharmaceuticals, Inc. | 24338-002 | 24338-002-30 | 30 TABLET in 1 BOTTLE (24338-002-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 1.25MG BASE;0.625MG;10MG | ||||
| Approval Date: | Jun 5, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 5, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 23, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 23, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF TREATING HYPERTENSION | ||||||||
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