ANDA 074506

UPSHER SMITH LABS

FDA Drug Application

Application #074506

Application Sponsors

ANDA 074506

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	200MG	0	CIMETIDINE	CIMETIDINE
002	TABLET;ORAL	300MG	0	CIMETIDINE	CIMETIDINE
003	TABLET;ORAL	400MG	0	CIMETIDINE	CIMETIDINE
004	TABLET;ORAL	800MG	0	CIMETIDINE	CIMETIDINE

FDA Submissions

	ORIG	1	AP	1996-01-24
LABELING; Labeling	SUPPL	2	AP	1997-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-04-07
LABELING; Labeling	SUPPL	4	AP	1998-08-10

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74506
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)