ANDA 212317

GLENMARK PHARMS LTD

FDA Drug Application

Application #212317

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 212317

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	60MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	90MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	120MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212317
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"90MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-22
        )

)