ANDA 090460

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090460

Application Sponsors

ANDA 090460

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;37.5MG

0

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-09-06
LABELING; Labeling	SUPPL	2	AP	2014-08-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-06-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-03-23	STANDARD
REMS; REMS	SUPPL	9	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90460
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","actionType":"325MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)