Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071425
Company: GALDERMA LABS LP

Products on ANDA 071425

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071425

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1988	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/1997	SUPPL-6	Labeling		Label is not available on this site.
11/01/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/19/1993	SUPPL-4	Labeling		Label is not available on this site.
10/30/1992	SUPPL-3	Labeling		Label is not available on this site.
11/06/1991	SUPPL-2	Labeling		Label is not available on this site.
08/29/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071425

DESOWEN

OINTMENT;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%	OINTMENT;TOPICAL	Prescription	No	AB	212473	ALEMBIC
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	210998	ENCUBE ETHICALS
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075751	FOUGERA PHARMS
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	209996	GLENMARK PHARMS LTD
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	Yes	AB	017426	PADAGIS US
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074254	TARO
DESOWEN	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	071425	GALDERMA LABS LP