Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211111
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription AB 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
06/04/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

FLUOCINONIDE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 211111 AMNEAL PHARMS LLC
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 200735 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 091282 GLENMARK GENERICS
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 090256 PERRIGO ISRAEL
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 200734 TARO
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 211758 TELIGENT PHARMA INC
VANOS FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription Yes AB 021758 MEDICIS

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