Application Sponsors
| ANDA 062949 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
| 001 | CREAM;TOPICAL | 100,000 UNITS/GM | 0 | NYSTATIN | NYSTATIN |
FDA Submissions
| ORIG | 1 | AP | 1988-06-13 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1994-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-08-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-06-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2001-10-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-10-03 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 62949
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NYSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/GM","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)