NDA 021793

MEDA PHARMS

FDA Drug Application

Application #021793

Documents

• Letter: 2005-06-14
• Letter: 2009-07-06
• Letter: 2009-10-26
• Letter: 2010-09-21
• Letter: 2011-08-05
• Letter: 2011-11-30
• Label: 2009-09-22
• Label: 2010-11-26
• Review: 2007-07-18
• Letter: 2010-11-22
• Label: 2005-06-14
• Label: 2010-09-10
• Label: 2011-12-02
• Review: 2011-02-15
• Medication Guide: 2011-12-02

Application Sponsors

NDA 021793

MEDA PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 5MG BASE	0	REGLAN ODT	METOCLOPRAMIDE HYDROCHLORIDE
002	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	0	REGLAN ODT	METOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-06-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-06-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2009-09-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2010-09-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2010-11-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2011-08-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2011-11-30	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0

CDER Filings

MEDA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21793
            [companyName] => MEDA PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/021793s011mg.pdf"]
            [products] => [{"drugName":"REGLAN ODT","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REGLAN ODT","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/30\/2011","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021793s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2010","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021793s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021793s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2009","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017854s051,021793s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021793lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REGLAN ODT","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"REGLAN ODT","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-11-30
        )

)