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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020666
Company: IMPAX LABS INC

Products on NDA 020666

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBENZA	ALBENDAZOLE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020666

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/11/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020666Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020666Orig1s012ltr.pdf
10/31/2018	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020666Orig1s011ltr.pdf
12/20/2017	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020666Orig1s010ltr.pdf
06/11/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020666Orig1s009ltr.pdf
10/20/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf
10/20/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf
08/20/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020666s004ltr.pdf

Labels for NDA 020666

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf
10/31/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf
10/31/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf
12/20/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf
06/11/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf
10/20/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf
10/20/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf
08/20/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf

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