Application Sponsors
ANDA 088994 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | PHENYLBUTAZONE | PHENYLBUTAZONE |
FDA Submissions
| ORIG | 1 | AP | 1985-12-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-07-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-06-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-04-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-03-03 | |
LABELING; Labeling | SUPPL | 8 | AP | 1989-06-28 | |
LABELING; Labeling | SUPPL | 9 | AP | 1989-11-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1992-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1992-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-10-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1994-12-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1998-12-01 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 88994
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"PHENYLBUTAZONE","activeIngredients":"PHENYLBUTAZONE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PHENYLBUTAZONE","submission":"PHENYLBUTAZONE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)