Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206134
Company: ZYDUS PHARMS

Products on ANDA 206134

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2021	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/12/2021	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/12/2021	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 206134

BUDESONIDE

CAPSULE, DELAYED RELEASE;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	206200	AMNEAL PHARMS
BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	090410	AUROBINDO PHARMA USA
BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	206623	DR REDDYS LABS SA
BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	207367	RISING
BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	206134	ZYDUS PHARMS
ENTOCORT EC	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021324	PADAGIS US