Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215328
Company: PADAGIS ISRAEL

Products on ANDA 215328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215328Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215328

BUDESONIDE

AEROSOL, FOAM;RECTAL; 2MG/ACTUATION
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription	No	AB	215328	PADAGIS ISRAEL
UCERIS	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription	Yes	AB	205613	SALIX