Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019779
Company: IMPRIMIS PHARMS USA
Company: IMPRIMIS PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IOPIDINE | APRACLONIDINE HYDROCHLORIDE | EQ 1% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/01/2018 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019779s025lbl.pdf | |
| 04/06/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019779s023lbl.pdf | |
| 12/15/2004 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf | |
| 12/15/2004 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf | |
| 03/22/2002 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19779S14lbl.pdf |