Application Sponsors
ANDA 072300 | CONTRACT PHARMACAL | |
Marketing Status
Application Products
001 | TABLET;ORAL | 800MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1988-07-01 | |
LABELING; Labeling | SUPPL | 2 | AP | 2016-05-09 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
CONTRACT PHARMACAL
cder:Array
(
[0] => Array
(
[ApplNo] => 72300
[companyName] => CONTRACT PHARMACAL
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)