Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090325
Company: AUROBINDO PHARMA USA

Products on ANDA 090325

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2010	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
12/21/2020	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/21/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/21/2020	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/12/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/11/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/11/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/07/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/02/2013	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
02/07/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/08/2011	SUPPL-5	Labeling		Label is not available on this site.