Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213811
Company: AMNEAL IRELAND LTD

Products on ANDA 213811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.04MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	No	Yes
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213811Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213811

BECLOMETHASONE DIPROPIONATE

AEROSOL, METERED;INHALATION; 0.04MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.04MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	213811	AMNEAL IRELAND LTD
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.04MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	214418	AUROLIFE PHARMA LLC

AEROSOL, METERED;INHALATION; 0.08MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	213811	AMNEAL IRELAND LTD
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	214418	AUROLIFE PHARMA LLC