Documents
Application Sponsors
| NDA 201152 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 400MG | 1 | VIRAMUNE XR | NEVIRAPINE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 100MG | 1 | VIRAMUNE XR | NEVIRAPINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2011-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2011-11-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2012-11-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2012-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2017-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2018-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-06-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 39 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 201152
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/201152s013lbl.pdf#page=18"]
[products] => [{"drugName":"VIRAMUNE XR","activeIngredients":"NEVIRAPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"VIRAMUNE XR","activeIngredients":"NEVIRAPINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/24\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201152s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201152s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201152s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2012","submission":"SUPPL-4","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201152s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201152s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201152s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201152s000lbl.pdf\"}]","notes":""}]
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[supplements] => [{"actionDate":"09\/24\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201152s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201152Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201152s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201152Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201152s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201152Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201152s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201152Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2012","submission":"SUPPL-4","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201152s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201152Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201152s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201152s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/06\/2011","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/020933s029,020636s038,201152s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-09-24
)
)