ANDA 204889

MACLEODS PHARMS LTD

FDA Drug Application

Application #204889

Documents

• Letter: 2017-10-11

Application Sponsors

ANDA 204889

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 75MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 150MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204889
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204889Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/13\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-13
        )

)