ZYDUS PHARMS USA INC FDA Approval ANDA 078899

ANDA 078899

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078899

Application Sponsors

ANDA 078899ZYDUS PHARMS USA INC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 5MG BASE0BROMOCRIPTINE MESYLATEBROMOCRIPTINE MESYLATE

FDA Submissions

ORIG1AP2008-07-30
LABELING; LabelingSUPPL2AP2012-08-13
LABELING; LabelingSUPPL7AP2021-01-19STANDARD
LABELING; LabelingSUPPL8AP2022-04-27STANDARD

Submissions Property Types

SUPPL2Null15
SUPPL7Null7
SUPPL8Null7

TE Codes

001PrescriptionAB

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
        )

)

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