Application Sponsors
| ANDA 078899 | ZYDUS PHARMS USA INC | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | EQ 5MG BASE | 0 | BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE |
FDA Submissions
| ORIG | 1 | AP | 2008-07-30 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-08-13 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-04-27 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 78899
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"BROMOCRIPTINE MESYLATE","activeIngredients":"BROMOCRIPTINE MESYLATE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BROMOCRIPTINE MESYLATE","submission":"BROMOCRIPTINE MESYLATE","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)