GRANULES PHARMS FDA Approval ANDA 213813

ANDA 213813

GRANULES PHARMS

FDA Drug Application

Application #213813

Application Sponsors

ANDA 213813GRANULES PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL5MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL10MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL15MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORAL20MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
005CAPSULE, EXTENDED RELEASE;ORAL25MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
006CAPSULE, EXTENDED RELEASE;ORAL30MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
007CAPSULE, EXTENDED RELEASE;ORAL35MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
008CAPSULE, EXTENDED RELEASE;ORAL40MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB
008PrescriptionAB

CDER Filings

GRANULES PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213813
            [companyName] => GRANULES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"35MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.