Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207133
Company: PERRIGO UK FINCO
Company: PERRIGO UK FINCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 08/30/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207133Orig1s000ltr.pdf |
FLURANDRENOLIDE
LOTION;TOPICAL; 0.05%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORDRAN | FLURANDRENOLIDE | 0.05% | LOTION;TOPICAL | Prescription | Yes | AT | 013790 | ALMIRALL |
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | LOTION;TOPICAL | Prescription | No | AT | 205343 | CINTEX SVCS |
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | LOTION;TOPICAL | Prescription | No | AT | 207133 | PERRIGO UK FINCO |
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