Documents
Application Sponsors
| NDA 020406 | TAKEDA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | 1 | PREVACID | LANSOPRAZOLE |
| 002 | CAPSULE, DELAYED REL PELLETS;ORAL | 30MG | 1 | PREVACID | LANSOPRAZOLE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1995-05-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1996-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1995-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1996-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1997-02-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 1997-04-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 1997-05-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 1996-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1997-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1997-06-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1998-03-12 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1997-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1997-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1997-09-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 1998-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1998-07-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1998-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1998-07-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1998-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 1999-01-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 1999-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1998-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 1999-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1999-11-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2000-11-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2000-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2000-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1999-11-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 38 | AP | 2001-05-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2000-10-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2001-05-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2001-06-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2000-12-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2001-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2001-12-05 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2002-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2002-03-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 47 | AP | 2002-07-31 | PRIORITY |
| LABELING; Labeling | SUPPL | 48 | AP | 2002-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2002-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2003-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2004-06-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 57 | AP | 2004-06-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 58 | AP | 2006-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2007-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2008-04-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 67 | AP | 2008-10-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 2008-09-08 | N/A |
| LABELING; Labeling | SUPPL | 71 | AP | 2009-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2010-05-12 | UNKNOWN |
| LABELING; Labeling | SUPPL | 74 | AP | 2010-09-03 | UNKNOWN |
| LABELING; Labeling | SUPPL | 75 | AP | 2011-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 76 | AP | 2011-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 77 | AP | 2011-05-20 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 78 | AP | 2012-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2012-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 80 | AP | 2015-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 81 | AP | 2014-12-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 82 | AP | 2016-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 2017-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 84 | AP | 2018-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 87 | AP | 2018-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 88 | AP | 2018-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 90 | AP | 2020-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 92 | AP | 2020-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 94 | AP | 2022-03-04 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 67 | Null | 8 |
| SUPPL | 71 | Null | 6 |
| SUPPL | 73 | Null | 31 |
| SUPPL | 74 | Null | 6 |
| SUPPL | 75 | Null | 6 |
| SUPPL | 76 | Null | 6 |
| SUPPL | 77 | Null | 6 |
| SUPPL | 78 | Null | 6 |
| SUPPL | 79 | Null | 6 |
| SUPPL | 80 | Null | 6 |
| SUPPL | 81 | Null | 7 |
| SUPPL | 82 | Null | 7 |
| SUPPL | 83 | Null | 15 |
| SUPPL | 84 | Null | 6 |
| SUPPL | 87 | Null | 7 |
| SUPPL | 88 | Null | 15 |
| SUPPL | 90 | Null | 31 |
| SUPPL | 92 | Null | 7 |
| SUPPL | 94 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 20406
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020406s092,021428s039lbl.pdf#page=44"]
[products] => [{"drugName":"PREVACID","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PREVACID","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/27\/2020","submission":"SUPPL-92","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020406s092,021428s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-92","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020406s092,021428s039lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2020","submission":"SUPPL-90","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020406s090,021428s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2018","submission":"SUPPL-88","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021428s028lbl020406s081lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-81","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021428s028lbl020406s081lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-78","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020406s078-021428s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2012","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020406s079,021428s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2011","submission":"SUPPL-76","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020406s076,021428s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2011","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020406s075,021428s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2011","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020406s071,021281s026,021428s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2008","submission":"SUPPL-67","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020406s067,021281s024,021428s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2007","submission":"SUPPL-64","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020406s064,021281s021,021428s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2006","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020406s058,021281s017,021428s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2004","submission":"SUPPL-57","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/020406s057_021281s014_021428s004lbl%20.pdf\"}]","notes":""},{"actionDate":"06\/15\/2004","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20406slr056_prevacid_lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2002","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21-428lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2002","submission":"SUPPL-47","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20406s47lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2002","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20406s45lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2001","submission":"SUPPL-38","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20406s38lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2000","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20406S33lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PREVACID","submission":"LANSOPRAZOLE","actionType":"15MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PREVACID","submission":"LANSOPRAZOLE","actionType":"30MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-11-27
)
)