Application Sponsors
ANDA 070050 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
001 | CREAM;TOPICAL | EQ 0.1% BASE | 0 | VALNAC | BETAMETHASONE VALERATE |
FDA Submissions
| ORIG | 1 | AP | 1984-10-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-09-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-01-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-11-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-11-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-02-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-03-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-11-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-12-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-05-30 | |
Submissions Property Types
SUPPL | 2 | 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 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 70050
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"VALNAC","activeIngredients":"BETAMETHASONE VALERATE","strength":"EQ 0.1% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VALNAC","submission":"BETAMETHASONE VALERATE","actionType":"EQ 0.1% BASE","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)