Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203378
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

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 ANDA REPOSITORY
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 202705 AKORN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 091306 IDENTI PHARMS INC
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 PERRIGO ISRAEL
FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 211815 GLENMARK PHARMS LTD

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