Documents
Application Sponsors
| NDA 008693 | PROCTER AND GAMBLE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | FURADANTIN | NITROFURANTOIN |
| 002 | TABLET;ORAL | 100MG | 0 | FURADANTIN | NITROFURANTOIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1953-02-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1976-06-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1976-05-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1979-03-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 1979-12-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-06-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1982-11-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 1993-05-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1983-07-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 1988-05-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 1998-02-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1993-08-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 1998-02-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 1997-03-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 30 | AP | 1997-07-16 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
CDER Filings
PROCTER AND GAMBLE
cder:Array
(
[0] => Array
(
[ApplNo] => 8693
[companyName] => PROCTER AND GAMBLE
[docInserts] => ["",""]
[products] => [{"drugName":"FURADANTIN","activeIngredients":"NITROFURANTOIN","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FURADANTIN","activeIngredients":"NITROFURANTOIN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FURADANTIN","submission":"NITROFURANTOIN","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FURADANTIN","submission":"NITROFURANTOIN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)