Application Sponsors
ANDA 072152 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 4MG BASE | 0 | ALBUTEROL SULFATE | ALBUTEROL SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1989-03-23 | |
LABELING; Labeling | SUPPL | 2 | AP | 1990-09-10 | |
LABELING; Labeling | SUPPL | 3 | AP | 1991-07-10 | |
LABELING; Labeling | SUPPL | 4 | AP | 1993-10-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-08-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1994-08-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-08-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-01-24 | |
LABELING; Labeling | SUPPL | 10 | AP | 1994-08-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-12-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-11-05 | |
LABELING; Labeling | SUPPL | 13 | AP | 1998-04-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-11-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-02-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-12-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-04-19 | |
Submissions Property Types
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 72152
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)