Documents
Application Sponsors
Marketing Status
Application Products
001 | OINTMENT;TOPICAL | 0.1% | 1 | CYCLOCORT | AMCINONIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1981-11-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-05-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-08-26 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2009-03-13 | |
LABELING; Labeling | SUPPL | 5 | AP | 1989-02-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-11-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-08-09 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2002-09-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-09-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-08-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-06-16 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 18498
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"CYCLOCORT","activeIngredients":"AMCINONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/03\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18498s8lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CYCLOCORT","submission":"AMCINONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2002-09-03
)
)