ANDA 080615

WATSON LABS TEVA

FDA Drug Application

Application #080615

Application Sponsors

ANDA 080615

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

DIMENHYDRINATE

DIMENHYDRINATE

FDA Submissions

	ORIG	1	AP	1974-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	154	AP	1982-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	157	AP	1986-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	159	AP	1988-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	161	AP	1988-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	162	AP	1988-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	164	AP	1989-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	165	AP	1989-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	166	AP	1989-09-27
LABELING; Labeling	SUPPL	167	AP	1991-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	168	AP	1996-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	169	AP	1999-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	170	AP	1998-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	171	AP	1999-02-19

Submissions Property Types

SUPPL	154	Null	0
SUPPL	157	Null	0
SUPPL	159	Null	0
SUPPL	161	Null	0
SUPPL	162	Null	0
SUPPL	163	Null	0
SUPPL	164	Null	0
SUPPL	165	Null	0
SUPPL	166	Null	0
SUPPL	168	Null	0
SUPPL	169	Null	0
SUPPL	170	Null	0
SUPPL	171	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80615
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMENHYDRINATE","activeIngredients":"DIMENHYDRINATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIMENHYDRINATE","submission":"DIMENHYDRINATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)