Documents
Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | EQ 50MG BASE/5ML | 0 | MINOCIN | MINOCYCLINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 1972-10-26 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-01-16 | |
LABELING; Labeling | SUPPL | 5 | AP | 1986-10-29 | |
LABELING; Labeling | SUPPL | 7 | AP | 1987-05-01 | |
LABELING; Labeling | SUPPL | 8 | AP | 1987-10-06 | |
LABELING; Labeling | SUPPL | 11 | AP | 2002-02-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-04-10 | |
LABELING; Labeling | SUPPL | 13 | AP | 2002-02-01 | |
LABELING; Labeling | SUPPL | 14 | AP | 1992-05-12 | |
LABELING; Labeling | SUPPL | 15 | AP | 2002-02-01 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 1995-08-08 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2002-02-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1998-08-12 | |
LABELING; Labeling | SUPPL | 19 | AP | 2002-05-31 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-03-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-01-28 | |
LABELING; Labeling | SUPPL | 22 | AP | 2005-02-17 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2004-05-27 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2004-05-27 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2005-09-28 | STANDARD |
LABELING; Labeling | SUPPL | 27 | AP | 2007-01-16 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2010-09-14 | UNKNOWN |
LABELING; Labeling | SUPPL | 29 | AP | 2015-02-25 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
LABELING; Labeling | SUPPL | 30 | AP | 2018-11-16 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 24 | Null | 9 |
SUPPL | 28 | Null | 31 |
SUPPL | 29 | Null | 6 |
SUPPL | 30 | Null | 7 |
CDER Filings
BAUSCH
cder:Array
(
[0] => Array
(
[ApplNo] => 50445
[companyName] => BAUSCH
[docInserts] => ["",""]
[products] => [{"drugName":"MINOCIN","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 50MG BASE\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/16\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050445s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050445s029lbl.pdf\"}]","notes":"Please see"},{"actionDate":"09\/14\/2010","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050445s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2007","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050444s045,050445s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050444s044lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MINOCIN","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2018-11-16
)
)