Documents
Application Sponsors
| NDA 020615 | MYLAN INSTITUTIONAL | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 1MG/10ML (0.1MG/ML) | 1 | DURACLON | CLONIDINE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 5MG/10ML (0.5MG/ML) | 1 | DURACLON | CLONIDINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1996-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-07-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2013-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2013-03-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2016-08-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 8 | Null | 14 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 20615
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"DURACLON","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DURACLON","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/28\/2010","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020615s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020615s002lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DURACLON","submission":"CLONIDINE HYDROCHLORIDE","actionType":"1MG\/10ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DURACLON","submission":"CLONIDINE HYDROCHLORIDE","actionType":"5MG\/10ML (0.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2010-07-28
)
)