Documents
Application Sponsors
Marketing Status
Application Products
001 | LOTION;TOPICAL | 0.1% | 1 | LOCOID | HYDROCORTISONE BUTYRATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2007-05-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2013-11-19 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2014-10-30 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
BAUSCH
cder:Array
(
[0] => Array
(
[ApplNo] => 22076
[companyName] => BAUSCH
[docInserts] => ["",""]
[products] => [{"drugName":"LOCOID","activeIngredients":"HYDROCORTISONE BUTYRATE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/30\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022076s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022076lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LOCOID","submission":"HYDROCORTISONE BUTYRATE","actionType":"0.1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-10-30
)
)