Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Discontinued | 002 |
Application Products
001 | GEL;TOPICAL | 5%;EQ 1% BASE | 1 | BENZACLIN | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
002 | GEL;TOPICAL | 5%;EQ 1% BASE | 0 | BENZACLIN | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2000-12-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-08-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-10-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-09-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-09-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-03-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-08-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-06-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-08-28 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2005-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2007-05-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2007-04-20 | N/A |
LABELING; Labeling | SUPPL | 34 | AP | 2009-06-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2010-06-14 | N/A |
LABELING; Labeling | SUPPL | 37 | AP | 2010-06-17 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2011-03-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2014-09-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2014-12-05 | STANDARD |
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 | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 35 | Null | 6 |
SUPPL | 37 | Null | 7 |
SUPPL | 40 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 44 | Null | 0 |
TE Codes
CDER Filings
BAUSCH
cder:Array
(
[0] => Array
(
[ApplNo] => 50756
[companyName] => BAUSCH
[docInserts] => ["",""]
[products] => [{"drugName":"BENZACLIN","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"BENZACLIN","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/02\/2011","submission":"SUPPL-40","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050756s040lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/17\/2010","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050756s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2009","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050756s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2007","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050756s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2007","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050756s027lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050756s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2002","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50756s7lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/50-756_Benzaclin_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BENZACLIN","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"5%;EQ 1% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BENZACLIN","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"5%;EQ 1% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2011-03-02
)
)