Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050611
Company: AZURITY
Company: AZURITY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PCE | ERYTHROMYCIN | 333MG | TABLET, COATED PARTICLES;ORAL | Discontinued | None | Yes | No |
| PCE | ERYTHROMYCIN | 500MG | TABLET, COATED PARTICLES;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/23/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf | |
| 02/02/2012 | SUPPL-35 | Labeling-Package Insert | 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/2012/050611s035lbl.pdf |
| 01/27/2011 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050611s027lbl.pdf | |
| 12/10/2008 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s032lbl.pdf | |
| 01/05/2008 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s029lbl.pdf | |
| 08/09/2006 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050611s022lbl.pdf |