ANDA 084276

ANI PHARMS INC

FDA Drug Application

Application #084276

Application Sponsors

ANDA 084276

ANI PHARMS INC

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

750MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1977-01-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1982-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1983-11-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1982-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1984-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1985-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1985-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1985-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1985-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1985-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1987-02-26
BIOEQUIV; Bioequivalence	SUPPL	32	AP	1988-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1988-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1988-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1988-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1998-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1998-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1998-09-22
LABELING; Labeling	SUPPL	42	AP	1998-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1999-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1999-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2001-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2002-11-13
LABELING; Labeling	SUPPL	52	AP	2007-09-28

Submissions Property Types

SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0

CDER Filings

ANI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84276
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)