Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074935
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2004 SUPPL-5 Labeling

Label is not available on this site.

07/27/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/28/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/28/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINONIDE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 072537 ACP NIMBLE
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription Yes AB 017373 CNTY LINE PHARMS
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 072933 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 074935 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 209030 TELIGENT PHARMA INC

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