Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021537
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRODEX | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021537s018lbl.pdf | |
| 02/21/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021537s017lbl.pdf | |
| 12/10/2015 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf |