Documents
Application Sponsors
| NDA 020763 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 2.5MG BASE | 1 | AMERGE | NARATRIPTAN HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 1MG BASE | 1 | AMERGE | NARATRIPTAN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1998-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-09-07 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2003-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2010-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-03-02 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-03-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2016-11-29 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 20763
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"AMERGE","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AMERGE","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/29\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020763s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020763s001s002s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2013","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020763s001s002s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2013","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020763s001s002s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020763s008s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2012","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020763s008s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2010","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020763s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20763lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AMERGE","submission":"NARATRIPTAN HYDROCHLORIDE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AMERGE","submission":"NARATRIPTAN HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-11-29
)
)