Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075331
Company: SUN PHARMA CANADA

Products on ANDA 075331

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075331

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/1999	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
01/08/2003	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075331

DIFLORASONE DIACETATE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075374	AVONDALE PHARMS
DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	207440	RISING
DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075331	SUN PHARMA CANADA
DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	210753	THE J MOLNER