ANDA 085380

MEDA PHARMS

FDA Drug Application

Application #085380

Documents

• Other Important Information from FDA: 2007-03-16

Application Sponsors

ANDA 085380

MEDA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

ELIXIR;ORAL

30MG/5ML

0

BUTISOL SODIUM

BUTABARBITAL SODIUM

FDA Submissions

	ORIG	1	AP	1978-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1987-02-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1990-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1990-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1990-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1992-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-03-13
LABELING; Labeling	SUPPL	24	AP	1999-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1999-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-05-03

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0

CDER Filings

MEDA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85380
            [companyName] => MEDA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTISOL SODIUM","activeIngredients":"BUTABARBITAL SODIUM","strength":"30MG\/5ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTISOL SODIUM","submission":"BUTABARBITAL SODIUM","actionType":"30MG\/5ML","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)