Documents
Application Sponsors
| NDA 018731 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BUSPAR | BUSPIRONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BUSPAR | BUSPIRONE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BUSPAR | BUSPIRONE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BUSPAR | BUSPIRONE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1986-09-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-12-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-12-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-04-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-07-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1989-07-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1987-08-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-06-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 1988-11-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1989-03-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1989-03-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1988-10-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1989-04-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 1991-07-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-01-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 1998-03-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1990-01-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1990-10-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-04-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 1993-09-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 27 | AP | 1996-04-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1996-03-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1996-06-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 1996-04-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-12-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 1998-05-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 1998-05-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1998-04-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1998-06-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1999-01-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 39 | AP | 2001-05-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1999-07-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1999-11-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2000-04-25 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 43 | AP | 2001-07-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 45 | AP | 2001-05-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 46 | AP | 2002-02-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 48 | AP | 2007-09-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 51 | AP | 2010-11-22 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 51 | Null | 0 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 18731
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"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":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"10MG **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":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"15MG **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":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"30MG **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"}]
[labels] => [{"actionDate":"11\/22\/2010","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018731s051lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2007","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018731s048lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2001","submission":"SUPPL-43","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/18731s43lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2001","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/18731s39s45lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2001","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/18731s39s45lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"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":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2010-11-22
)
)