ANDA 208783

NOVAST LABS

FDA Drug Application

Application #208783

Application Sponsors

ANDA 208783

NOVAST LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	120MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	180MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	240MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	300MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
005	CAPSULE, EXTENDED RELEASE;ORAL	360MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB3
002	Prescription	AB3
003	Prescription	AB3
004	Prescription	AB3
005	Prescription	AB3

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208783
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-14
        )

)