ANDA 087845

MALLINCKRODT INC

FDA Drug Application

Application #087845

Application Sponsors

ANDA 087845

MALLINCKRODT INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

TOFRANIL

IMIPRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-05-22
LABELING; Labeling	SUPPL	9	AP	1993-02-02
LABELING; Labeling	SUPPL	12	AP	1994-12-20
LABELING; Labeling	SUPPL	14	AP	1998-09-01
LABELING; Labeling	SUPPL	20	AP	2004-08-31
LABELING; Labeling	SUPPL	21	AP	2005-06-09
LABELING; Labeling	SUPPL	22	AP	2005-09-12
LABELING; Labeling	SUPPL	24	AP	2007-06-25
LABELING; Labeling	SUPPL	25	AP	2007-09-27
LABELING; Labeling	SUPPL	27	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	28	AP	2017-06-29	STANDARD

Submissions Property Types

SUPPL	27	Null	15
SUPPL	28	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MALLINCKRODT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87845
            [companyName] => MALLINCKRODT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOFRANIL","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOFRANIL","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)