Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203378
Company: LYNE
Company: LYNE
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 |
---|---|---|---|---|---|---|---|
04/25/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203378Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2022 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 | TASMAN PHARMA |
FLUOCINONIDE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 211815 | GLENMARK PHARMS LTD |