Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202578
Company: MYLAN

Products on ANDA 202578

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202578

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202578Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2020	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/18/2020	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/18/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/18/2020	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.