Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074204
Company: ACP NIMBLE
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 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
06/13/1995 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
12/29/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/01/1996 SUPPL-1 Manufacturing (CMC)

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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