Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210361
Company: JOURNEY
Company: JOURNEY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QBREXZA | GLYCOPYRRONIUM TOSYLATE | EQ 2.4% BASE | CLOTH;TOPICAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
06/28/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210361lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210361Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210361Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/28/2022 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210361Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210361Orig1s005ltr.pdf | |
07/20/2020 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210361Orig1s003Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210361Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/28/2022 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210361Orig1s005lbl.pdf | |
10/28/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210361Orig1s005lbl.pdf | |
07/20/2020 | SUPPL-3 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210361Orig1s003Lbl.pdf | |
06/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210361lbl.pdf |