ANDA 078004

ACME LABS

FDA Drug Application

Application #078004

Documents

• Letter: 2012-05-18

Application Sponsors

ANDA 078004

ACME LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

	ORIG	1	AP	2012-05-17
LABELING; Labeling	SUPPL	2	AP	2020-05-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-05-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACME LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78004
            [companyName] => ACME LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOPIDOGREL BISULFATE","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)