Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072494
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription AB2 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
01/19/1989 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
04/13/2004 SUPPL-7 Labeling

Label is not available on this site.

09/13/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/06/1995 SUPPL-3 Labeling

Label is not available on this site.

05/15/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/11/1991 SUPPL-1 Labeling

Label is not available on this site.

FLUOCINONIDE EMULSIFIED BASE

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 074204 ACP NIMBLE
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 076586 FOUGERA PHARMS
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 072494 TARO PHARM INDS LTD
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 072490 TEVA
LIDEX-E FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription Yes AB2 016908 CNTY LINE PHARMS

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