Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076753
Company: TARO

Products on ANDA 076753

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076753

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2004	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
06/11/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/04/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076753

BETAMETHASONE DIPROPIONATE

OINTMENT, 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	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	074304	ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	218289	AUROBINDO PHARMA LTD
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	075373	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	209106	LUPIN LTD
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	076753	TARO
DIPROLENE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	Yes	AB	018741	ORGANON