Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074027
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESONIDE DESONIDE 0.05% 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
09/28/1992 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
06/16/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/23/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DESONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 074027 ACP NIMBLE
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 209729 GLENMARK PHARMS
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription Yes AB 017010 PERRIGO NEW YORK
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 073548 TARO
DESOWEN DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 019048 GALDERMA LABS LP

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