ANDA 212184

GLENMARK PHARMS LTD

FDA Drug Application

Application #212184

Documents

• Letter: 2021-07-07
• Review: 2021-08-23

Application Sponsors

ANDA 212184

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	300MG	0	THEOPHYLLINE	THEOPHYLLINE
002	TABLET, EXTENDED RELEASE;ORAL	450MG	0	THEOPHYLLINE	THEOPHYLLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212184
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-03
        )

)