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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207554
Company: PAI HOLDINGS PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;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
03/18/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

FLUOCINONIDE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 071535 COSETTE
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 209699 ENCUBE ETHICALS
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 072934 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 209118 GLASSHOUSE PHARMS
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 209283 MACLEODS PHARMS LTD
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 206003 NOVEL LABS INC
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 207554 PAI HOLDINGS PHARM
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 074799 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 208948 ZYDUS PHARMS
LIDEX FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription Yes AT 018849 ALVOGEN
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