Details for New Drug Application (NDA): 021883
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The generic ingredient in DALVANCE is dalbavancin hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
Summary for 021883
| Tradename: | DALVANCE |
| Applicant: | Abbvie |
| Ingredient: | dalbavancin hydrochloride |
| Patents: | 1 |
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 | Allergan, 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: | AP | RLD: | Yes | ||||
| Patent: | 6,900,175 | Patent Expiration: | May 23, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) IN ADULT AND PEDIATRIC PATIENTS USING A TWO-DOSE REGIMEN OF DALBAVANCIN | ||||||||
Expired US Patents for NDA 021883
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | DALVANCE | dalbavancin hydrochloride | POWDER;INTRAVENOUS | 021883-001 | May 23, 2014 | 7,115,564 | ⤷ Start Trial |
| Abbvie | DALVANCE | dalbavancin hydrochloride | POWDER;INTRAVENOUS | 021883-001 | May 23, 2014 | 8,143,212 | ⤷ Start Trial |
| Abbvie | DALVANCE | dalbavancin hydrochloride | POWDER;INTRAVENOUS | 021883-001 | May 23, 2014 | 7,119,061 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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