Documents
Application Sponsors
| NDA 018891 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | 1 | CATAPRES-TTS-1 | CLONIDINE |
| 002 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.2MG/24HR | 1 | CATAPRES-TTS-2 | CLONIDINE |
| 003 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.3MG/24HR | 1 | CATAPRES-TTS-3 | CLONIDINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1984-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1985-09-18 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1988-05-11 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1988-05-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-10-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1988-12-07 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1989-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-06-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1989-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1992-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1992-11-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1993-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1996-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1996-09-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1996-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1996-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-10-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1999-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2004-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2006-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2009-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2010-04-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 28 | AP | 2012-05-31 | UNKNOWN |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
LAVIPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 18891
[companyName] => LAVIPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"CATAPRES-TTS-1","activeIngredients":"CLONIDINE","strength":"0.1MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CATAPRES-TTS-2","activeIngredients":"CLONIDINE","strength":"0.2MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CATAPRES-TTS-3","activeIngredients":"CLONIDINE","strength":"0.3MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/31\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018891s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2010","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018891s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2009","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018891s025lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CATAPRES-TTS-1","submission":"CLONIDINE","actionType":"0.1MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CATAPRES-TTS-2","submission":"CLONIDINE","actionType":"0.2MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CATAPRES-TTS-3","submission":"CLONIDINE","actionType":"0.3MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-05-31
)
)