Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
| 002 | SYRUP;ORAL | 1.5MG/5ML;5MG/5ML | 1 | HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1943-03-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 1988-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1988-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1988-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1988-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1992-04-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-07-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1999-04-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2001-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2009-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2017-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2018-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2021-09-27 | STANDARD |
Submissions Property Types
| SUPPL | 14 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
GENUS
cder:Array
(
[0] => Array
(
[ApplNo] => 5213
[companyName] => GENUS
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/005213s039lbl.pdf#page=27"]
[products] => [{"drugName":"HYCODAN","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYCODAN","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG\/5ML;5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"06\/28\/2018","submission":"SUPPL-39","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/005213s039lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2018","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/005213s039lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/005213s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/005213s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2009","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/005213s037lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HYCODAN","submission":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","actionType":"1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HYCODAN","submission":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","actionType":"1.5MG\/5ML;5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-06-28
)
)