Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215266
Company: PADAGIS ISRAEL

Products on ANDA 215266

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215266Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215266

HALOBETASOL PROPIONATE

AEROSOL, FOAM;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%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	215266	PADAGIS ISRAEL
LEXETTE	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	Yes	AB	210566	MAYNE PHARMA