Documents
Application Sponsors
| NDA 017443 | PAR STERILE PRODUCTS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE;ORAL | 25MG | 1 | DANTRIUM | DANTROLENE SODIUM |
| 002 | CAPSULE;ORAL | 100MG | 1 | DANTRIUM | DANTROLENE SODIUM |
| 003 | CAPSULE;ORAL | 50MG | 1 | DANTRIUM | DANTROLENE SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1974-01-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1975-02-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1975-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1975-11-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1975-07-15 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1975-10-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1976-05-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1976-07-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1976-05-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1977-06-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 1977-06-15 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1977-10-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1977-06-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1979-07-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1979-08-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1979-08-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1979-09-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1981-03-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 24 | AP | 1981-10-09 | |
| LABELING; Labeling | SUPPL | 25 | AP | 1982-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1983-11-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1983-05-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1983-05-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1983-05-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1983-05-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1983-05-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1985-05-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 36 | AP | 1985-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1989-06-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1990-02-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1991-05-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1992-01-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 43 | AP | 2012-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1996-09-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1997-03-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 46 | AP | 2012-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1997-10-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 48 | AP | 2012-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2012-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 2014-03-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2015-07-08 | PRIORITY |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 17443
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"DANTRIUM","activeIngredients":"DANTROLENE SODIUM","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DANTRIUM","activeIngredients":"DANTROLENE SODIUM","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DANTRIUM","activeIngredients":"DANTROLENE SODIUM","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/17\/2012","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017443s043s046s048s049lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017443s043s046s048s049lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017443s043s046s048s049lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-43","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017443s043s046s048s049lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DANTRIUM","submission":"DANTROLENE SODIUM","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DANTRIUM","submission":"DANTROLENE SODIUM","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DANTRIUM","submission":"DANTROLENE SODIUM","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-07-17
)
)