Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022327
Company: PERRIGO PHARMA INTL
Company: PERRIGO PHARMA INTL
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 |
---|---|---|---|---|---|
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. |
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 |
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 |