ANDA 075285

L PERRIGO CO

FDA Drug Application

Application #075285

Documents

• Letter: 1998-10-29
• Review: 1998-10-29

Application Sponsors

ANDA 075285

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG

0

CIMETIDINE

CIMETIDINE

FDA Submissions

	ORIG	1	AP	1998-10-29
LABELING; Labeling	SUPPL	2	AP	1999-04-13
LABELING; Labeling	SUPPL	3	AP	1999-06-10
LABELING; Labeling	SUPPL	5	AP	2001-06-11
LABELING; Labeling	SUPPL	6	AP	2001-11-05
LABELING; Labeling	SUPPL	8	AP	2003-01-22
LABELING; Labeling	SUPPL	30	AP	2009-02-27
LABELING; Labeling	SUPPL	44	AP	2020-02-21	STANDARD

Submissions Property Types

SUPPL

44

Null

15

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75285
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)