Application Sponsors
Marketing Status
Application Products
001 | AEROSOL;NASAL | EQ 0.1MG PHOSPHATE/INH | 0 | DEXACORT | DEXAMETHASONE SODIUM PHOSPHATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1965-12-17 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 1977-09-12 | |
LABELING; Labeling | SUPPL | 13 | AP | 1978-10-19 | |
LABELING; Labeling | SUPPL | 14 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 16 | AP | 1979-08-06 | |
LABELING; Labeling | SUPPL | 18 | AP | 1979-08-17 | |
LABELING; Labeling | SUPPL | 19 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 20 | AP | 1981-11-18 | |
LABELING; Labeling | SUPPL | 21 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 22 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 23 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 24 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 25 | AP | 1989-05-18 | |
LABELING; Labeling | SUPPL | 26 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 27 | AP | 2007-12-07 | |
LABELING; Labeling | SUPPL | 28 | AP | 2007-12-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1991-09-11 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 1994-05-03 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2007-12-07 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2007-12-07 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2007-12-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1995-07-10 | STANDARD |
Submissions Property Types
CDER Filings
UCB INC
cder:Array
(
[0] => Array
(
[ApplNo] => 14242
[companyName] => UCB INC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXACORT","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 0.1MG PHOSPHATE\/INH","dosageForm":"AEROSOL;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DEXACORT","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 0.1MG PHOSPHATE\/INH","submissionClassification":"AEROSOL;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)