Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077455
Company: WATSON LABS INC

• Other Important Information from FDA

Products on ANDA 077455

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 077455

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2008	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
01/04/2021	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2021	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/14/2014	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
03/11/2013	SUPPL-20	REMS-Modified		Label is not available on this site.
04/16/2012	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/22/2010	SUPPL-11	REMS-Proposal		Label is not available on this site.
11/16/2009	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/26/2009	SUPPL-7	Labeling		Label is not available on this site.
07/19/2010	SUPPL-4	Labeling		Label is not available on this site.
09/23/2008	SUPPL-1	Labeling		Label is not available on this site.