Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078404
Company: IMPAX LABS INC

Products on ANDA 078404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	AN	No	No
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078404

BUDESONIDE

SUSPENSION;INHALATION; 0.25MG/2ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	205710	CIPLA
BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	078404	IMPAX LABS INC
BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	078202	NEPHRON
BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	211922	SUN PHARM
BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	077519	TEVA PHARMS
PULMICORT RESPULES	BUDESONIDE	0.25MG/2ML	SUSPENSION;INHALATION	Prescription	Yes	AN	020929	ASTRAZENECA

SUSPENSION;INHALATION; 0.5MG/2ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	205710	CIPLA
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	216667	EUGIA PHARMA
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	078404	IMPAX LABS INC
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	210897	LUPIN
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	078202	NEPHRON
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	211922	SUN PHARM
BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	077519	TEVA PHARMS
PULMICORT RESPULES	BUDESONIDE	0.5MG/2ML	SUSPENSION;INHALATION	Prescription	Yes	AN	020929	ASTRAZENECA