Documents
Application Sponsors
| ANDA 091052 | MYLAN PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET, DELAYED RELEASE;ORAL | EQ 150MG BASE | 0 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE |
FDA Submissions
| ORIG | 1 | AP | 2012-02-08 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2016-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-12-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91052
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)