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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021566
Company: TAKEDA PHARMS NA

Other Important Information from FDA

Products on NDA 021566

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREVACID IV	LANSOPRAZOLE	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021566

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21566_prevacid_lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21566ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021566s000_PrevacidTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2009	SUPPL-5		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021566s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021566s005ltr.pdf
05/16/2007	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021566s004ltr.pdf
12/29/2006	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021566s002ltr.pdf
04/05/2005	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021566s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021566s001ltr.pdf

Labels for NDA 021566

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2009	SUPPL-5	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021566s005lbl.pdf
04/05/2005	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021566s001lbl.pdf
05/27/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21566_prevacid_lb.pdf

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