Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076543
Company: TARO

Products on ANDA 076543

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076543

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2003	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
07/07/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/02/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/26/2009	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076543

BETAMETHASONE DIPROPIONATE

CREAM, 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	CREAM, AUGMENTED;TOPICAL	Prescription	No	AB	076215	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED;TOPICAL	Prescription	No	AB	078930	GLENMARK PHARMS INC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED;TOPICAL	Prescription	No	AB	076592	PADAGIS ISRAEL
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED;TOPICAL	Prescription	No	AB	076543	TARO