Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213264
Company: TASMAN PHARMA

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
02/05/2021 ORIG-1 Approval STANDARD

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 ANDA REPOSITORY
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 091306 AMNEAL
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 SOLARIS PHARMA CORP
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

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