Documents
Application Sponsors
ANDA 212747 | MAKRO TECHNLOGIES, INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | TABLET;ORAL | 267MG | 0 | PIRFENIDONE | PIRFENIDONE |
002 | TABLET;ORAL | 534MG | 0 | PIRFENIDONE | PIRFENIDONE |
003 | TABLET;ORAL | 801MG | 0 | PIRFENIDONE | PIRFENIDONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-01-21 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
MAKRO TECHNLOGIES, INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212747
[companyName] => MAKRO TECHNLOGIES, INC
[docInserts] => ["",""]
[products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"534MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"801MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212747Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-01-21
)
)