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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212212
Company: TEVA PHARMS USA INC

Products on ANDA 212212

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	No	No
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212212

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212212

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

AEROSOL, METERED;INHALATION; 0.08MG/INH;0.0045MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREYNA	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	211699	MYLAN
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	212212	TEVA PHARMS USA INC
SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB	021929	ASTRAZENECA

AEROSOL, METERED;INHALATION; 0.16MG/INH;0.0045MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREYNA	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	211699	MYLAN
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	212212	TEVA PHARMS USA INC
SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB	021929	ASTRAZENECA

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