Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202849
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | 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 |
---|---|---|---|---|---|---|---|
07/17/2017 | ORIG-1 | Approval |
Label is not available on this site. |
FLUOCINOLONE ACETONIDE
OIL/DROPS;OTIC; 0.01%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DERMOTIC | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | Yes | AT | 019452 | HILL DERMAC |
FLAC | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 210736 | PATRIN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 203378 | LYNE |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 202849 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 212762 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 213264 | TRUPHARMA |
FLUOCINONIDE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 211815 | GLENMARK PHARMS LTD |