ANDA 090404

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090404

Application Sponsors

ANDA 090404

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-01-31
LABELING; Labeling	SUPPL	3	AP	2015-11-09	STANDARD
REMS; REMS	SUPPL	8	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90404
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)