Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214418
Company: AUROLIFE PHARMA LLC

Products on ANDA 214418

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	No
BECLOMETHASONE DIPROPIONATE	BECLOMETHASONE DIPROPIONATE	0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214418

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