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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019048
Company: GALDERMA LABS LP

Products on NDA 019048

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOWEN	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019048

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.

Therapeutic Equivalents for NDA 019048

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	214396	ALEMBIC
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	210198	CADILA
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	074027	COSETTE
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	209729	GLENMARK PHARMS
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	Yes	AB	017010	PADAGIS US
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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