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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021507
Company: TAKEDA PHARMS NA

Medication Guide

Other Important Information from FDA

Products on NDA 021507

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREVACID NAPRAPAC 250 (COPACKAGED)	LANSOPRAZOLE; NAPROXEN	15MG,N/A;N/A,250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	Discontinued	None	Yes	No
PREVACID NAPRAPAC 375 (COPACKAGED)	LANSOPRAZOLE; NAPROXEN	15MG,N/A;N/A,375MG	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	Discontinued	None	No	No
PREVACID NAPRAPAC 500 (COPACKAGED)	LANSOPRAZOLE; NAPROXEN	15MG,N/A;N/A,500MG	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021507

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2003	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21507ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21507_PrevacidTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2009	SUPPL-9		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021507s009ltr.pdf
10/20/2008	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021507s008ltr.pdf
08/31/2006	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf
08/31/2006	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf
04/12/2006	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021507s004ltr.pdf

Labels for NDA 021507

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2009	SUPPL-9	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf
08/31/2006	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf
08/31/2006	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf

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