Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077284
Company: ANCHEN PHARMS

Products on ANDA 077284

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077284

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2006	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077284lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077284s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077284Orig1Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2023	SUPPL-54	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2023	SUPPL-52	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2023	SUPPL-47	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/12/2019	SUPPL-42	Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/25/2017	SUPPL-39	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/25/2017	SUPPL-36	Labeling-Container/Carton Labels		Label is not available on this site.
08/25/2017	SUPPL-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2014	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
10/31/2011	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/30/2011	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
11/19/2010	SUPPL-20	REMS-Proposal		Label is not available on this site.
01/25/2011	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/20/2011	SUPPL-11	Labeling		Label is not available on this site.
09/17/2007	SUPPL-8	Labeling		Label is not available on this site.

Labels for ANDA 077284

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077284lbl.pdf