Application Sponsors
ANDA 089567 | SUN PHARM INDS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 0.75MG | 0 | ORTHO-EST | ESTROPIPATE |
FDA Submissions
| ORIG | 1 | AP | 1991-02-27 | |
LABELING; Labeling | SUPPL | 2 | AP | 1993-06-21 | |
LABELING; Labeling | SUPPL | 3 | AP | 1993-09-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-05-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-02-22 | |
LABELING; Labeling | SUPPL | 6 | AP | 1996-07-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-06-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-03-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-03-19 | |
LABELING; Labeling | SUPPL | 15 | AP | 2003-06-11 | |
LABELING; Labeling | SUPPL | 17 | AP | 2005-04-07 | |
LABELING; Labeling | SUPPL | 20 | AP | 2004-07-21 | |
Submissions Property Types
SUPPL | 1 | Null | 1 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89567
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ORTHO-EST","activeIngredients":"ESTROPIPATE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ORTHO-EST","submission":"ESTROPIPATE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)