Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204929
Company: RISING

Products on ANDA 204929

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204929

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2017	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
08/05/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204929

ZILEUTON

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211390	AIZANT
ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215742	ANNORA PHARMA
ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204929	RISING
ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212670	STRIDES PHARMA