Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204548
Company: TEVA PHARMS USA

Products on ANDA 204548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/2016	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-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/29/2016	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 204548

BUDESONIDE

SUSPENSION;INHALATION; 1MG/2ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	205710	CIPLA
BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	211922	SUN PHARM
BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION;INHALATION	Prescription	No	AN	204548	TEVA PHARMS USA
PULMICORT RESPULES	BUDESONIDE	1MG/2ML	SUSPENSION;INHALATION	Prescription	Yes	AN	020929	ASTRAZENECA