Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 0.1MG | 0 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 0.2MG | 0 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-09-30 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-08-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 12 | Null | 7 |
TE Codes
CDER Filings
ANCHEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 202984
[companyName] => ANCHEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.2MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/30\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202984Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/04\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/04\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/29\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/29\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-04
)
)