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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022327
Company: PERRIGO PHARMA INTL

Other Important Information from FDA

Summary Review

Products on NDA 022327

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREVACID 24 HR	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022327

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2009	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022327s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022327_prevacid_24hr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022327s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2022	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022327Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022327Orig1s031ltr.pdf
06/23/2022	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022327Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022327Orig1s030ltr.pdf
03/01/2022	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022327Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022327Orig1s029ltr.pdf
04/09/2019	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022327Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022327Orig1s027ltr.pdf
11/28/2017	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022327Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022327Orig1s026ltr.pdf
02/24/2017	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022327Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022327Orig1s024ltr.pdf
06/30/2015	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022327Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022327Orig1s022ltr.pdf
06/12/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/19/2012	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327Orig1s020ltr.pdf
04/23/2012	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327s019ltr.pdf
04/05/2012	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327s018ltr.pdf
10/31/2011	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s017ltr.pdf
09/27/2011	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s016ltr.pdf
04/19/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s013ltr.pdf
01/26/2011	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s009ltr.pdf
12/01/2010	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022327Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022327s008ltr.pdf
09/15/2010	SUPPL-4	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022327s004ltr.pdf
04/01/2010	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 022327

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2022	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022327Orig1s031lbl.pdf
06/23/2022	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022327Orig1s030lbl.pdf
03/01/2022	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022327Orig1s029lbl.pdf
04/09/2019	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022327Orig1s027lbl.pdf
11/28/2017	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022327Orig1s026lbl.pdf
02/24/2017	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022327Orig1s024lbl.pdf
06/30/2015	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022327Orig1s022lbl.pdf
09/19/2012	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s020lbl.pdf
04/23/2012	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s019lbl.pdf
04/05/2012	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s018lbl.pdf
10/31/2011	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s017lbl.pdf
09/27/2011	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s016lbl.pdf
04/19/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s013lbl.pdf
01/26/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s009lbl.pdf
12/01/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022327Orig1s008lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

PREVACID 24 HR

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED REL PELLETS;ORAL; 15MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	202194	DR REDDYS LABS LTD
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	202727	GLENMARK PHARMS INC
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	203306	NATCO
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	202319	PERRIGO R AND D
PREVACID 24 HR	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	Yes	022327	PERRIGO PHARMA INTL

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