ANDA 080259

ANI PHARMS INC

FDA Drug Application

Application #080259

Application Sponsors

ANDA 080259

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

100MG PROMPT

0

PROMPT PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	1978-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1987-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1987-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1987-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1987-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1987-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1989-06-26
LABELING; Labeling	SUPPL	37	AP	1989-08-07
LABELING; Labeling	SUPPL	38	AP	1992-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1993-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1993-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1993-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1997-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1998-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1999-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1999-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2000-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2000-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2002-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2002-07-29

Submissions Property Types

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	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80259
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMPT PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG PROMPT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMPT PHENYTOIN SODIUM","submission":"PHENYTOIN SODIUM","actionType":"100MG PROMPT","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)