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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 |
Generic Entry Opportunity Date for 021883
Generic Entry Date for 021883*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
POWDER;IV (INFUSION) |
*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: 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;INTRAVENOUS | 021883 | NDA | Durata Therapeutics Inc. | 57970-100 | 57970-100-01 | 1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | 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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