ANDA 070581

PAR PHARM INC

FDA Drug Application

Application #070581

Application Sponsors

ANDA 070581

PAR PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

METOCLOPRAMIDE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-06-15
LABELING; Labeling	SUPPL	6	AP	1987-06-23
LABELING; Labeling	SUPPL	9	AP	1986-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-11-23
LABELING; Labeling	SUPPL	12	AP	1988-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1991-07-10
LABELING; Labeling	SUPPL	15	AP	1991-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-01-27
LABELING; Labeling	SUPPL	18	AP	1999-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-05-26
LABELING; Labeling	SUPPL	20	AP	2002-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-11-02
LABELING; Labeling	SUPPL	22	AP	2002-05-23
LABELING; Labeling	SUPPL	27	AP	2005-05-05
LABELING; Labeling	SUPPL	35	AP	2010-03-11
LABELING; Labeling	SUPPL	37	AP	2011-02-28
LABELING; Labeling	SUPPL	38	AP	2012-02-21
LABELING; Labeling	SUPPL	44	AP	2019-07-30	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	35	Null	7
SUPPL	37	Null	7
SUPPL	38	Null	15
SUPPL	44	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70581
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)