ANDA 040397

EPIC PHARMA LLC

FDA Drug Application

Application #040397

Documents

• Letter: 2000-09-21

Application Sponsors

ANDA 040397

EPIC PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

350MG

0

CARISOPRODOL

CARISOPRODOL

FDA Submissions

	ORIG	1	AP	2000-09-21
LABELING; Labeling	SUPPL	2	AP	2009-01-29
LABELING; Labeling	SUPPL	5	AP	2009-03-19
LABELING; Labeling	SUPPL	6	AP	2011-07-14
LABELING; Labeling	SUPPL	7	AP	2020-04-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-04-22	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	8	Null	7

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40397
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARISOPRODOL","submission":"CARISOPRODOL","actionType":"350MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)