Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210566
Company: MAYNE PHARMA
Company: MAYNE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEXETTE | HALOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/24/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210566s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210566Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210566Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/2022 | SUPPL-5 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210566Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210566Orig1s005ltr.pdf | |
08/18/2021 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210566s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210566Orig1s003ltr.pdf | |
04/23/2020 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210566s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210566Orig1s002ltr.pdf | |
04/19/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210566s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/19/2022 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210566Orig1s005lbl.pdf | |
08/18/2021 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210566s003lbl.pdf | |
04/23/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210566s002lbl.pdf | |
04/19/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210566s001lbl.pdf | |
04/19/2019 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210566s001lbl.pdf | |
04/19/2019 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210566s001lbl.pdf | |
05/24/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210566s000lbl.pdf |
LEXETTE
AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB | 215266 | PADAGIS ISRAEL |
LEXETTE | HALOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | Yes | AB | 210566 | MAYNE PHARMA |