Documents
Application Sponsors
ANDA 215197 | NANJING KING-FRIEND | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 0 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-08-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
NANJING KING-FRIEND
cder:Array
(
[0] => Array
(
[ApplNo] => 215197
[companyName] => NANJING KING-FRIEND
[docInserts] => ["",""]
[products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215197Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-08-20
)
)