Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 100MG | 1 | RESCRIPTOR | DELAVIRDINE MESYLATE |
| 002 | TABLET;ORAL | 200MG | 1 | RESCRIPTOR | DELAVIRDINE MESYLATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1997-04-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-10-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-07-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 1999-08-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2001-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2002-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2012-08-10 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 41 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 18 | Null | 7 |
CDER Filings
VIIV HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 20705
[companyName] => VIIV HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"RESCRIPTOR","activeIngredients":"DELAVIRDINE MESYLATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RESCRIPTOR","activeIngredients":"DELAVIRDINE MESYLATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/10\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020705s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2001","submission":"SUPPL-8","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20705S8lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/1999","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20705s03lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RESCRIPTOR","submission":"DELAVIRDINE MESYLATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RESCRIPTOR","submission":"DELAVIRDINE MESYLATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-08-10
)
)