Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073548
Company: SUN PHARMA CANADA

Products on ANDA 073548

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1992	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
01/15/2016	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
06/18/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/18/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/20/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/17/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/17/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/01/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/01/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073548

DESONIDE

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	073548	SUN PHARMA CANADA
DESOWEN	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	019048	GALDERMA LABS LP