DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021883
NDA 021883 describes DALVANCE, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DALVANCE profile page.
The generic ingredient in DALVANCE is dalbavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
The generic ingredient in DALVANCE is dalbavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
Summary for 021883
| Tradename: | DALVANCE |
| Applicant: | Allergan Sales Llc |
| Ingredient: | dalbavancin hydrochloride |
| Patents: | 4 |
Pharmacology for NDA: 021883
| Ingredient-type | Lipoglycopeptides |
Suppliers and Packaging for NDA: 021883
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DALVANCE | dalbavancin hydrochloride | POWDER;IV (INFUSION) | 021883 | NDA | Durata Therapeutics Inc. | 57970-100 | N | 57970-100-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;IV (INFUSION) | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | May 23, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 20, 2019 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI) | ||||||||
| Regulatory Exclusivity Expiration: | May 23, 2024 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | May 23, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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