Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076508
Company: SUN PHARMA CANADA

Products on ANDA 076508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076508

BETAMETHASONE DIPROPIONATE

GEL, AUGMENTED;TOPICAL; EQ 0.05% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED;TOPICAL	Prescription	No	AB	075276	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED;TOPICAL	Prescription	No	AB	076508	SUN PHARMA CANADA