Application Sponsors
ANDA 214366 | MSN LABS PVT LTD | |
Marketing Status
None (Tentative Approval) | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | EQ 25MG BASE | 0 | ERLOTINIB HYDROCHLORIDE | ERLOTINIB HYDROCHLORIDE |
002 | TABLET;ORAL | EQ 100MG BASE | 0 | ERLOTINIB HYDROCHLORIDE | ERLOTINIB HYDROCHLORIDE |
003 | TABLET;ORAL | EQ 150MG BASE | 0 | ERLOTINIB HYDROCHLORIDE | ERLOTINIB HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-10-08 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
MSN LABS PVT LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 214366
[companyName] => MSN LABS PVT LTD
[docInserts] => ["",""]
[products] => [{"drugName":"Erlotinib Hydrochloride","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-10-08
)
)