Application Sponsors
| ANDA 205694 | GLAND PHARMA LTD | |
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 | AP | 2016-01-21 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-07-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205694
[companyName] => GLAND PHARMA LTD
[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":"01\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/19\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-19
)
)