ANDA 072370

WATSON LABS INC

FDA Drug Application

Application #072370

Application Sponsors

ANDA 072370

WATSON LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

DIAZEPAM

DIAZEPAM

FDA Submissions

	ORIG	1	AP	1993-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-08-15
LABELING; Labeling	SUPPL	3	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-08-15
LABELING; Labeling	SUPPL	6	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-02-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-08-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-08-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	2023-01-17	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72370
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIAZEPAM","submission":"DIAZEPAM","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)