Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210872
Company: ZUREX PHARMA
Company: ZUREX PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZURAGARD | ISOPROPYL ALCOHOL | 70% | SOLUTION;TOPICAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/26/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210872Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210872Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210872Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/24/2021 | SUPPL-1 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210872Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210872Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/24/2021 | SUPPL-1 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210872Orig1s001Lbl.pdf | |
04/26/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210872Orig1s000lbl.pdf |
ZURAGARD
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 70%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ZURAGARD | ISOPROPYL ALCOHOL | 70% | SOLUTION;TOPICAL | Over-the-counter | Yes | 210872 | ZUREX PHARMA |