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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020528
Company: ABBVIE

Other Important Information from FDA

Products on NDA 020528

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAVIK	TRANDOLAPRIL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MAVIK	TRANDOLAPRIL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MAVIK	TRANDOLAPRIL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 020528

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020528Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2017	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020528s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020528Orig1s025ltr.pdf
01/29/2016	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020528Orig1s024ltr.pdf
12/24/2014	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020528s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020528Orig1s023ltr.pdf
06/13/2013	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/11/2012	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528Orig1s021ltr.pdf
01/23/2012	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf
09/14/2011	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020528s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s019ltr.pdf
01/23/2012	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s018ltr.pdf
11/10/2011	SUPPL-17	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s017ltr.pdf
04/08/2009	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020528s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020528s016ltr.pdf
04/20/2010	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020528s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020528s012ltr.pdf
02/06/2004	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20528slr008ltr.pdf
08/20/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/14/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/05/2000	SUPPL-4	Labeling		Label is not available on this site.
10/26/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/24/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/02/1997	SUPPL-1	Efficacy-New Indication	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020528_s001ap.pdf

Labels for NDA 020528

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2017	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020528s025lbl.pdf
01/29/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf
12/24/2014	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020528s023lbl.pdf
09/11/2012	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s021lbl.pdf
01/23/2012	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf
01/23/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf
09/14/2011	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020528s019lbl.pdf
04/20/2010	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020528s012lbl.pdf
04/08/2009	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020528s016lbl.pdf

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