ANDA 075051

VISTAPHARM

FDA Drug Application

Application #075051

Documents

• Letter: 2001-01-26
• Label: 2001-01-26
• Review: 2002-01-04

Application Sponsors

ANDA 075051

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

METOCLOPRAMIDE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2001-01-26
REMS; REMS	SUPPL	2	AP	2010-07-30
LABELING; Labeling	SUPPL	3	AP	2011-02-28
LABELING; Labeling	SUPPL	4	AP	2012-08-31	STANDARD

Submissions Property Types

SUPPL	2	Null	8
SUPPL	4	Null	15

TE Codes

001

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75051
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/26\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2001\\\/75-051_Metoclopramide_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-01-26
        )

)