Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202161
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESONIDE DESONIDE 0.05% LOTION;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
10/31/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202161Orig1s000ltr.pdf

DESONIDE

LOTION;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% LOTION;TOPICAL Prescription No AB 075860 FOUGERA PHARMS
DESONIDE DESONIDE 0.05% LOTION;TOPICAL Prescription No AB 209494 GLENMARK PHARMS
DESONIDE DESONIDE 0.05% LOTION;TOPICAL Prescription No AB 202161 TARO
DESONIDE DESONIDE 0.05% LOTION;TOPICAL Prescription No AB 207855 TELIGENT PHARMA INC
DESOWEN DESONIDE 0.05% LOTION;TOPICAL Prescription No AB 072354 GALDERMA LABS LP

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