Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211410
Company: TELIGENT PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription AB1 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
10/16/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

FLUOCINONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073085 ACP NIMBLE
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073030 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription Yes AB1 019117 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 071500 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 211410 TELIGENT PHARMA INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 072488 TEVA

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