Application Sponsors
NDA 018790 | SUN PHARM INDS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 40MG | 0 | FUROSEMIDE | FUROSEMIDE |
FDA Submissions
| ORIG | 1 | AP | 1983-10-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1985-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1985-10-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1986-01-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1986-12-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1986-12-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-02-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1987-07-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1987-12-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1989-02-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1989-02-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1989-02-24 | |
LABELING; Labeling | SUPPL | 24 | AP | 1988-12-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1991-02-05 | |
LABELING; Labeling | SUPPL | 26 | AP | 1989-05-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1991-02-05 | |
LABELING; Labeling | SUPPL | 28 | AP | 1991-04-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1992-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1992-04-03 | |
LABELING; Labeling | SUPPL | 32 | AP | 1992-05-01 | |
LABELING; Labeling | SUPPL | 33 | AP | 1992-08-11 | |
LABELING; Labeling | SUPPL | 34 | AP | 1993-08-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1994-10-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1994-12-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1998-12-01 | |
Submissions Property Types
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 0 |
SUPPL | 37 | Null | 0 |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 18790
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)