Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NUBAIN | NALBUPHINE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NUBAIN | NALBUPHINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1979-05-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1980-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1980-02-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1981-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1981-04-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1982-05-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1982-05-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1982-05-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1982-05-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1984-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1984-03-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1986-10-23 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1983-02-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1983-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1983-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1984-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1984-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1984-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1984-11-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1987-08-04 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1988-11-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1987-12-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1988-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1990-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1994-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1993-10-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1995-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2003-04-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2002-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2002-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2002-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2005-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2019-10-07 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | 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 | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 42 | Null | 15 |
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 18024
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"NUBAIN","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUBAIN","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"20MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018024s042lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018024s041lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2005","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/018024s040lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NUBAIN","submission":"NALBUPHINE HYDROCHLORIDE","actionType":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NUBAIN","submission":"NALBUPHINE HYDROCHLORIDE","actionType":"20MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-07
)
)