Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077415
Company: IMPAX LABS

Products on ANDA 077415

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 077415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2006	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2023	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
08/02/2023	SUPPL-39	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2023	SUPPL-38	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2020	SUPPL-36	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/26/2017	SUPPL-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/26/2017	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/26/2017	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/01/2014	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
03/29/2012	SUPPL-18	Labeling-Package Insert	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf
08/30/2011	SUPPL-17	Labeling-Package Insert	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf
05/13/2010	SUPPL-15	REMS-Proposal		Label is not available on this site.
01/22/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/26/2008	SUPPL-7	Labeling		Label is not available on this site.
11/26/2008	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/10/2008	SUPPL-5	Labeling		Label is not available on this site.
09/17/2007	SUPPL-3	Labeling		Label is not available on this site.
09/17/2007	SUPPL-2	Labeling		Label is not available on this site.