Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021883
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DALVANCE | DALBAVANCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2021 | SUPPL-10 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021883s010lbl.pdf | |
| 07/24/2018 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021883s007lbl.pdf | |
| 01/20/2016 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021883s003lbl.pdf |
| 05/23/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf |