Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019048
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOWEN 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
12/14/1984 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/13/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/11/1995 SUPPL-12 Labeling

Label is not available on this site.

01/18/1994 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/30/1993 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/30/1991 SUPPL-7 Labeling

Label is not available on this site.

08/18/1989 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1989 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/23/1988 SUPPL-4 Labeling

Label is not available on this site.

10/25/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1985 SUPPL-1 Labeling

Label is not available on this site.

DESOWEN

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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