Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | RETROVIR | ZIDOVUDINE |
| 002 | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | RETROVIR | ZIDOVUDINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1995-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1998-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2001-03-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-04-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2001-10-05 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2002-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2002-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2003-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2006-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2006-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2008-09-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2009-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2010-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2011-11-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 23 | AP | 2012-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2014-12-23 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
CDER Filings
VIIV HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 20518
[companyName] => VIIV HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"RETROVIR","activeIngredients":"ZIDOVUDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RETROVIR","activeIngredients":"ZIDOVUDINE","strength":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/23\/2014","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019910s041lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2012","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019655s053,019910s040,020518s023lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019655s052,019910s039,020518s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2010","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020518s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019655s048,020518s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2008","submission":"SUPPL-16","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019910s033,019655s046,020518s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2006","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020518s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2006","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019655s41,019910s29,020518s13lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2003","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19655slr039,19910slr027,20518slr011_retrovir_lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2002","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2001","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20518s8lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2001","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20518S4lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RETROVIR","submission":"ZIDOVUDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RETROVIR","submission":"ZIDOVUDINE","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-12-23
)
)