Documents
Application Sponsors
Marketing Status
Application Products
001 | CREAM;TOPICAL | 1% | 1 | ELIDEL | PIMECROLIMUS |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2001-12-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2003-10-15 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2004-11-24 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2006-01-19 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2007-08-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2007-09-14 | N/A |
LABELING; Labeling | SUPPL | 14 | AP | 2010-07-20 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2014-03-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2014-06-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2014-09-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2014-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2016-06-09 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 6 |
SUPPL | 4 | Null | 0 |
SUPPL | 14 | Null | 6 |
SUPPL | 18 | Null | 6 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
TE Codes
CDER Filings
BAUSCH
cder:Array
(
[0] => Array
(
[ApplNo] => 21302
[companyName] => BAUSCH
[docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088587.pdf"]
[products] => [{"drugName":"ELIDEL","activeIngredients":"PIMECROLIMUS","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/28\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021302s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2010","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021302s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021302s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2006","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021302s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2004","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21302s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2003","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21302scp004_elidel_lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21302lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ELIDEL","submission":"PIMECROLIMUS","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-03-28
)
)