Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE;ORAL | 15MG | 1 | RESTORIL | TEMAZEPAM |
| 002 | CAPSULE;ORAL | 30MG | 1 | RESTORIL | TEMAZEPAM |
| 003 | CAPSULE;ORAL | 7.5MG | 1 | RESTORIL | TEMAZEPAM |
| 004 | CAPSULE;ORAL | 22.5MG | 1 | RESTORIL | TEMAZEPAM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1981-02-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1981-05-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1981-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1982-10-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 1991-10-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1984-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1985-08-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1985-07-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1986-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1986-04-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1987-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1987-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1987-09-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 1991-10-25 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1990-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1990-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1990-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1989-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1990-02-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1990-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 1994-07-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1994-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1994-03-29 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2000-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1993-04-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1994-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1992-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 1992-04-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1994-07-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1994-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1992-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1993-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 1992-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1994-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 1993-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1993-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1995-02-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1994-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2000-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1995-12-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1995-12-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1999-04-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1999-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2002-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2010-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2004-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2008-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2008-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2016-12-16 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 65 | AP | 2019-02-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 67 | AP | 2021-02-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 71 | AP | 2023-01-13 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 64 | Null | 15 |
| SUPPL | 65 | Null | 6 |
| SUPPL | 67 | Null | 6 |
| SUPPL | 71 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 18163
[companyName] => SPECGX LLC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018163s065lbl.pdf#page=13"]
[products] => [{"drugName":"RESTORIL","activeIngredients":"TEMAZEPAM","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RESTORIL","activeIngredients":"TEMAZEPAM","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"RESTORIL","activeIngredients":"TEMAZEPAM","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RESTORIL","activeIngredients":"TEMAZEPAM","strength":"22.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/06\/2019","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018163s065lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-64","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018163s064lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018163s064lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2010","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018163s054lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2008","submission":"SUPPL-59","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018163s058s059lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2008","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018163s058s059lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RESTORIL","submission":"TEMAZEPAM","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RESTORIL","submission":"TEMAZEPAM","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RESTORIL","submission":"TEMAZEPAM","actionType":"7.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RESTORIL","submission":"TEMAZEPAM","actionType":"22.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-02-06
)
)