Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | EQ 20MG BASE/ML | 1 | ZIAGEN | ABACAVIR SULFATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-12-17 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2000-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2000-07-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-07-13 | PRIORITY |
LABELING; Labeling | SUPPL | 6 | AP | 2002-01-28 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2002-06-04 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2002-10-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-12-24 | PRIORITY |
LABELING; Labeling | SUPPL | 10 | AP | 2002-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2003-07-17 | STANDARD |
EFFICACY; Efficacy | SUPPL | 13 | AP | 2004-04-15 | UNKNOWN |
EFFICACY; Efficacy | SUPPL | 14 | AP | 2004-08-02 | UNKNOWN |
LABELING; Labeling | SUPPL | 15 | AP | 2004-07-26 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2006-08-11 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2007-05-07 | STANDARD |
EFFICACY; Efficacy | SUPPL | 20 | AP | 2008-07-18 | UNKNOWN |
LABELING; Labeling | SUPPL | 22 | AP | 2008-12-19 | STANDARD |
REMS; REMS | SUPPL | 24 | AP | 2010-08-04 | N/A |
REMS; REMS | SUPPL | 26 | AP | 2011-05-13 | N/A |
LABELING; Labeling | SUPPL | 27 | AP | 2011-11-18 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 28 | AP | 2012-03-15 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2012-05-18 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2013-09-11 | STANDARD |
EFFICACY; Efficacy | SUPPL | 31 | AP | 2015-03-23 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2015-02-19 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2015-09-30 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2017-03-20 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2018-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2018-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2020-11-24 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 41 |
SUPPL | 5 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 13 | Null | 9 |
SUPPL | 14 | Null | 31 |
SUPPL | 24 | Null | 7 |
SUPPL | 26 | Null | 7 |
SUPPL | 27 | Null | 15 |
SUPPL | 28 | Null | 6 |
SUPPL | 29 | Null | 6 |
SUPPL | 30 | Null | 6 |
SUPPL | 31 | Null | 7 |
SUPPL | 32 | Null | 7 |
SUPPL | 34 | Null | 7 |
SUPPL | 35 | Null | 15 |
SUPPL | 36 | Null | 6 |
SUPPL | 37 | Null | 15 |
SUPPL | 38 | Null | 6 |
TE Codes
CDER Filings
VIIV HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 20978
[companyName] => VIIV HLTHCARE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020977s033s034,020978s036s037lbl.pdf#page=27"]
[products] => [{"drugName":"ZIAGEN","activeIngredients":"ABACAVIR SULFATE","strength":"EQ 20MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
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[originalApprovals] => [{"actionDate":"ZIAGEN","submission":"ABACAVIR SULFATE","actionType":"EQ 20MG BASE\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-05-09
)
)