Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 300MG BASE;150MG;300MG | 0 | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2013-12-05 | |
LABELING; Labeling | SUPPL | 5 | AP | 2020-12-22 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-12-22 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-12-22 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2020-12-22 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2022-04-06 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 5 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 10 | Null | 15 |
SUPPL | 12 | Null | 15 |
SUPPL | 13 | Null | 7 |
TE Codes
CDER Filings
LUPIN LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202912
[companyName] => LUPIN LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE","strength":"EQ 300MG BASE;150MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/05\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202912Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-12-05
)
)