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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208851
Company: MYLAN

Products on ANDA 208851

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208851

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208851

BUDESONIDE

TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205457	ACTAVIS LABS FL INC
BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208851	MYLAN
UCERIS	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	203634	SALIX

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