Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072354
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOWEN DESONIDE 0.05% LOTION;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/1992 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/072354Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

06/12/1998 SUPPL-6 Labeling

Label is not available on this site.

06/12/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/28/1995 SUPPL-4 Labeling

Label is not available on this site.

07/28/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/01/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/19/1993 SUPPL-1 Labeling

Label is not available on this site.

DESOWEN

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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