Documents
Application Sponsors
ANDA 213698 | GRACE CONSULTING SERVICES INC. | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;ORAL | 1MG/5ML | 0 | GLYCOPYRROLATE | GLYCOPYRROLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-09-15 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
GRACE CONSULTING SERVICES INC.
cder:Array
(
[0] => Array
(
[ApplNo] => 213698
[companyName] => GRACE CONSULTING SERVICES INC.
[docInserts] => ["",""]
[products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"1MG\/5ML","dosageForm":"LIQUID;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213698Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-09-15
)
)