Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075860
Company: FOUGERA PHARMS
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
03/19/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75860.ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2003 SUPPL-5 Labeling

Label is not available on this site.

12/03/2003 SUPPL-1 Labeling

Label is not available on this site.

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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