ANDA 207237

NOSTRUM LABS INC

FDA Drug Application

Application #207237

Application Sponsors

ANDA 207237

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	CARISOPRODOL	CARISOPRODOL
002	TABLET;ORAL	350MG	0	CARISOPRODOL	CARISOPRODOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-05-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-05-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207237
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/01\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-01
        )

)