Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072354
Company: GALDERMA LABS LP

Products on ANDA 072354

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072354

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.

Therapeutic Equivalents for ANDA 072354

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	213632	ALEMBIC
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
DESOWEN	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	072354	GALDERMA LABS LP