Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208124
Company: LUPIN
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOXIMETASONE | DESOXIMETASONE | 0.25% | SPRAY;TOPICAL | Prescription | AT | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/16/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208124Orig1s000ltr.pdf |
DESOXIMETASONE
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 |