Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073548
Company: TARO
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
06/30/1992 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
01/15/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

06/18/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/20/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/01/1996 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.

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
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 210198 ZYDUS PHARMS
DESOWEN DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 019048 GALDERMA LABS LP

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