Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090982
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;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 |
---|---|---|---|---|---|---|---|
04/25/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090982Orig1s000ltr.pdf |
FLUOCINOLONE ACETONIDE
OIL;TOPICAL; 0.01%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DERMA-SMOOTHE/FS | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | Yes | AT | 019452 | HILL DERMAC |
FLUCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 210556 | GLENMARK PHARMS LTD |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 090982 | LYNE |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 203377 | LYNE |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 207345 | NOVEL LABS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 207347 | NOVEL LABS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202847 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202848 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 212760 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 212761 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202368 | TARO |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 209336 | TARO |
FLUOCINONIDE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 210539 | GLENMARK PHARMS LTD |