Application Sponsors
| ANDA 084306 | NOVARTIS PHARMS CORP | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 1% | 0 | MYDRIACYL | TROPICAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1974-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1985-05-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-05-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1984-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1989-04-26 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1989-05-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-06-04 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1997-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1993-06-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1992-11-05 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1993-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1995-10-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-09-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-03-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1999-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1999-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1999-04-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2001-03-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2001-03-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2002-12-23 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2003-10-31 | |
Submissions Property Types
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
TE Codes
CDER Filings
ALCON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 84306
[companyName] => ALCON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MYDRIACYL","activeIngredients":"TROPICAMIDE","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MYDRIACYL","submission":"TROPICAMIDE","actionType":"1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)