Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076994
Company: TARO

Products on ANDA 076994

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076994

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076994ltr.pdf

Therapeutic Equivalents for ANDA 076994

HALOBETASOL PROPIONATE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	077109	COSETTE
HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	076872	PADAGIS ISRAEL
HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	213560	QUAGEN
HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	076994	TARO