Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022327
Company: GLAXOSMITHKLINE CONS
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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 207157 LANNETT CO INC
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 203187 MYLAN
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 203306 NATCO PHARMA LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 202319 PERRIGO R AND D
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 202727 WOCKHARDT LTD
PREVACID 24 HR LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter Yes 022327 GLAXOSMITHKLINE CONS

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