ANDA 040823

NOVAST LABS

FDA Drug Application

Application #040823

Application Sponsors

ANDA 040823

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

350MG

0

CARISOPRODOL

CARISOPRODOL

FDA Submissions

	ORIG	1	AP	2008-10-22
LABELING; Labeling	SUPPL	2	AP	2020-04-24	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40823
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARISOPRODOL","submission":"CARISOPRODOL","actionType":"350MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)