Documents
Application Sponsors
| NDA 050582 | MAYNE PHARMA INTL | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 100MG BASE | 1 | DORYX | DOXYCYCLINE HYCLATE |
| 002 | CAPSULE, DELAYED RELEASE;ORAL | EQ 75MG BASE | 1 | DORYX | DOXYCYCLINE HYCLATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1985-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1985-09-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1985-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1986-05-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-08-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1991-08-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-09-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-05-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2002-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2003-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2004-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2005-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2008-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2011-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2015-09-02 | 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 | 2018-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2020-03-02 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | 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 | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 22 | Null | 9 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 7 |
CDER Filings
MAYNE PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 50582
[companyName] => MAYNE PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/02\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050582s031lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050582s030lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050582s029lbl.pdf\"}]","notes":"Please see"},{"actionDate":"02\/07\/2008","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050582s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2005","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050582s024lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-03-02
)
)