Documents
Application Sponsors
| NDA 018276 | PHARMACIA AND UPJOHN | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 0.25MG | 1 | XANAX | ALPRAZOLAM |
| 002 | TABLET;ORAL | 0.5MG | 1 | XANAX | ALPRAZOLAM |
| 003 | TABLET;ORAL | 1MG | 1 | XANAX | ALPRAZOLAM |
| 004 | TABLET;ORAL | 2MG | 1 | XANAX | ALPRAZOLAM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1981-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1983-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1983-12-08 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1987-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1987-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-11-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1987-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1986-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1987-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1990-11-06 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1990-10-23 | |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1990-11-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1988-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1988-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1988-08-03 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1990-10-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1989-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1994-06-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1993-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1993-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 1992-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1993-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1996-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 1996-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 1998-11-24 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2000-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1999-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2002-11-07 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2004-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2004-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2011-06-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 45 | AP | 2011-08-23 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2014-08-08 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2016-12-16 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 55 | AP | 2021-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2021-02-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 59 | AP | 2023-01-13 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 55 | Null | 6 |
| SUPPL | 58 | Null | 6 |
| SUPPL | 59 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 18276
[companyName] => UPJOHN
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/018276s058lbl.pdf#page=27"]
[products] => [{"drugName":"XANAX","activeIngredients":"ALPRAZOLAM","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"XANAX","activeIngredients":"ALPRAZOLAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"XANAX","activeIngredients":"ALPRAZOLAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"XANAX","activeIngredients":"ALPRAZOLAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/01\/2021","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/018276s055lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2021","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/018276s058lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-52","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018276s052lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018276s052lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2011","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018276s045lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2011","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018276s044,021434s006lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"XANAX","submission":"ALPRAZOLAM","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XANAX","submission":"ALPRAZOLAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XANAX","submission":"ALPRAZOLAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XANAX","submission":"ALPRAZOLAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-03-01
)
)