Documents
Application Sponsors
| NDA 011559 | PAR STERILE PRODUCTS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 500MG/VIAL | 1 | BREVITAL SODIUM | METHOHEXITAL SODIUM |
| 002 | INJECTABLE;INJECTION | 2.5GM/VIAL | 1 | BREVITAL SODIUM | METHOHEXITAL SODIUM |
| 003 | INJECTABLE;INJECTION | 5GM/VIAL | 0 | BREVITAL SODIUM | METHOHEXITAL SODIUM |
| 004 | INJECTABLE;INJECTION | 200MG/VIAL | 0 | BREVITAL SODIUM | METHOHEXITAL SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1960-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1969-12-11 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1975-06-13 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1976-05-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1979-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1981-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1988-07-08 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1992-12-18 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1992-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1994-06-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1995-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-02-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-07-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 1998-01-30 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 1998-01-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 30 | AP | 1997-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2001-07-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2003-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2004-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2008-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2014-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2014-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2014-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2017-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2020-10-29 | STANDARD |
Submissions Property Types
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 57 | Null | 15 |
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 11559
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"BREVITAL SODIUM","activeIngredients":"METHOHEXITAL SODIUM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"BREVITAL SODIUM","activeIngredients":"METHOHEXITAL SODIUM","strength":"2.5GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BREVITAL SODIUM","activeIngredients":"METHOHEXITAL SODIUM","strength":"5GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BREVITAL SODIUM","activeIngredients":"METHOHEXITAL SODIUM","strength":"200MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/27\/2017","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/011559s051lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2014","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/011559s045lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2008","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/011559s041lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2004","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/11559slr037_brevital_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BREVITAL SODIUM","submission":"METHOHEXITAL SODIUM","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BREVITAL SODIUM","submission":"METHOHEXITAL SODIUM","actionType":"2.5GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BREVITAL SODIUM","submission":"METHOHEXITAL SODIUM","actionType":"5GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BREVITAL SODIUM","submission":"METHOHEXITAL SODIUM","actionType":"200MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2017-04-27
)
)