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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022497
Company: TWI PHARMS

Medication Guide

Summary Review

Products on NDA 022497

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FORFIVO XL	BUPROPION HYDROCHLORIDE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022497

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2011	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022497s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022497s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497_forfivo_xl_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022497s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022497Orig1s008ltr.pdf
05/04/2017	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022497Orig1s004ltr.pdf
08/30/2016	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf
07/17/2014	SUPPL-2	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022497Orig1s002ltr.pdf

Labels for NDA 022497

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022497s008lbl.pdf
05/04/2017	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf
05/04/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf
08/30/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf
08/30/2016	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf
07/17/2014	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf
11/10/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022497s000lbl.pdf

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