Application Sponsors
| NDA 017717 | BAYER HEALTHCARE LLC | |
Marketing Status
Application Products
| 002 | TABLET;VAGINAL | 100MG | 1 | GYNE-LOTRIMIN | CLOTRIMAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1976-03-24 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1977-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1979-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1979-07-16 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1980-09-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1980-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1981-08-05 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1981-11-12 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1982-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1986-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-06-18 | |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1990-11-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1992-06-23 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1992-04-14 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1992-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-02-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-03-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1999-11-03 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
CDER Filings
BAYER HEALTHCARE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 17717
[companyName] => BAYER HEALTHCARE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"GYNE-LOTRIMIN","activeIngredients":"CLOTRIMAZOLE","strength":"100MG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GYNE-LOTRIMIN","submission":"CLOTRIMAZOLE","actionType":"100MG","submissionClassification":"TABLET;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)