Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204141
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPICORT | DESOXIMETASONE | 0.25% | SPRAY;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
04/11/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204141Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141_topicort_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2021 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204141s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204141Orig1s009ltr.pdf | |
12/16/2015 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204141Orig1s004ltr.pdf | |
09/23/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/10/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/18/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/07/2021 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204141s009lbl.pdf | |
12/16/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf | |
04/11/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf |
TOPICORT
SPRAY;TOPICAL; 0.25%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESOXIMETASONE | DESOXIMETASONE | 0.25% | SPRAY;TOPICAL | Prescription | No | AT | 208124 | LUPIN |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | SPRAY;TOPICAL | Prescription | No | AT | 206441 | PADAGIS ISRAEL |
TOPICORT | DESOXIMETASONE | 0.25% | SPRAY;TOPICAL | Prescription | Yes | AT | 204141 | TARO |