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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073552
Company: SUN PHARMA CANADA

Products on ANDA 073552

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1992	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
05/26/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/15/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/15/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/06/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073552

BETAMETHASONE DIPROPIONATE

CREAM;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	CREAM;TOPICAL	Prescription	No	AB	070885	ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	219348	AUROBINDO PHARMA LTD
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	210217	COSETTE PHARMS NC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	Yes	AB	019137	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	073552	SUN PHARMA CANADA
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	208885	ZYDUS PHARMS

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