Application Sponsors
| ANDA 202275 | EMCURE PHARMS LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 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
| ORIG | 1 | AP | 2013-10-31 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-05-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
CDER Filings
EMCURE PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202275
[companyName] => EMCURE PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/25\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-05-25
)
)