Documents
Application Sponsors
| NDA 019574 | CASPER PHARMA LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | THALITONE | CHLORTHALIDONE |
| 002 | TABLET;ORAL | 25MG | 0 | THALITONE | CHLORTHALIDONE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1988-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1992-10-15 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1993-06-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1994-04-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-06-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-10-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1999-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2004-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2018-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-09-17 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 17 | Null | 6 |
TE Codes
CDER Filings
CASPER PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 19574
[companyName] => CASPER PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"THALITONE","activeIngredients":"CHLORTHALIDONE","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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy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":"THALITONE","activeIngredients":"CHLORTHALIDONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/17\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019574s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019574s016lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"THALITONE","submission":"CHLORTHALIDONE","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":"THALITONE","submission":"CHLORTHALIDONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2019-09-17
)
)