Documents
Application Sponsors
| NDA 017407 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 0.1MG | 1 | CATAPRES | CLONIDINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 0.2MG | 1 | CATAPRES | CLONIDINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 0.3MG | 1 | CATAPRES | CLONIDINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1974-09-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1976-07-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1976-10-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1977-01-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1976-12-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1981-02-05 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1979-09-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1978-11-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1980-12-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1980-02-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1980-09-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1980-09-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1981-02-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1981-02-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1981-04-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1981-08-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1982-11-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1987-09-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1984-04-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1985-03-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1985-10-02 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1986-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1987-09-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 1987-03-26 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1988-06-20 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1996-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 1996-08-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-11-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1998-04-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1999-04-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 2010-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2009-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2010-04-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 37 | AP | 2012-05-31 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2015-05-21 | PRIORITY |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 36 | Null | 31 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 38 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 17407
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"CATAPRES","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CATAPRES","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CATAPRES","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/31\/2012","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017407s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2010","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017407s036lbl.pdf\"}]","notes":""},{"actionDate":"01\/05\/2010","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017407s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2009","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017407s034lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CATAPRES","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CATAPRES","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CATAPRES","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-05-31
)
)