Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050297
Company: AZURITY
Company: AZURITY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| E.E.S. | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/15/2012 | SUPPL-31 | 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/2012/050297s031lbl.pdf |
| 12/10/2008 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf | |
| 01/05/2008 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s027lbl.pdf | |
| 08/10/2006 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf |