ANDA 074415

NOSTRUM LABS INC

FDA Drug Application

Application #074415

Documents

• Letter: 1998-06-08
• Review: 1998-06-08

Application Sponsors

ANDA 074415

NOSTRUM LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

1GM

0

SUCRALFATE

SUCRALFATE

FDA Submissions

	ORIG	1	AP	1998-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-02-02
LABELING; Labeling	SUPPL	6	AP	2007-09-19
LABELING; Labeling	SUPPL	8	AP	2008-01-16
LABELING; Labeling	SUPPL	19	AP	2015-10-30	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	1
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74415
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCRALFATE","activeIngredients":"SUCRALFATE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUCRALFATE","submission":"SUCRALFATE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)