Details for New Drug Application (NDA): 220256
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NDA 220256 describes JAVADIN, 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 JAVADIN profile page.
The generic ingredient in JAVADIN is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
The generic ingredient in JAVADIN is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
Summary for 220256
| Tradename: | JAVADIN |
| Applicant: | Azurity |
| Ingredient: | clonidine hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 220256
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 220256
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JAVADIN | clonidine hydrochloride | SOLUTION;ORAL | 220256 | NDA | Azurity Pharmaceuticals, Inc. | 24338-115 | 24338-115-01 | 1 BOTTLE in 1 CARTON (24338-115-01) / 250 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.02MG/ML | ||||
| Approval Date: | Oct 23, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 12,233,049 | Patent Expiration: | Jul 15, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,440,474 | Patent Expiration: | Jul 15, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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