Documents
Application Sponsors
| NDA 022327 | PERRIGO PHARMA INTL | |
Marketing Status
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | 1 | PREVACID 24 HR | LANSOPRAZOLE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2009-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2010-04-01 | N/A |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-09-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2010-12-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2011-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2011-04-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2012-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2012-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-09-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2013-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2015-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2017-11-28 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2019-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2022-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2022-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2022-12-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 6 |
CDER Filings
PERRIGO PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 22327
[companyName] => PERRIGO PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"PREVACID 24 HR","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/09\/2019","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022327Orig1s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022327Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022327Orig1s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2015","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022327Orig1s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022327Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2012","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022327Orig1s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022327Orig1s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2011","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022327Orig1s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2011","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022327Orig1s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2011","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022327Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022327Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022327Orig1s008lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PREVACID 24 HR","submission":"LANSOPRAZOLE","actionType":"15MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-09
)
)