Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | 60MG | 0 | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE |
002 | CAPSULE, DELAYED RELEASE;ORAL | 30MG | 0 | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-04-19 | |
LABELING; Labeling | SUPPL | 2 | AP | 2022-05-03 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2022-05-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2022-06-16 | UNKNOWN |
LABELING; Labeling | SUPPL | 9 | AP | 2022-08-03 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 6 | Null | 7 |
SUPPL | 9 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202294
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXLANSOPRAZOLE","activeIngredients":"DEXLANSOPRAZOLE","strength":"60MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/19\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202294Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202294Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202294Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-10-01
)
)