ANDA 210153

ZYDUS PHARMS

FDA Drug Application

Application #210153

Application Sponsors

ANDA 210153

ZYDUS PHARMS

Marketing Status

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

Application Products

001	TABLET;SUBLINGUAL	0.3MG	0	NITROGLYCERIN	NITROGLYCERIN
002	TABLET;SUBLINGUAL	0.4MG	0	NITROGLYCERIN	NITROGLYCERIN
003	TABLET;SUBLINGUAL	0.6MG	0	NITROGLYCERIN	NITROGLYCERIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210153
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.3MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.4MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.6MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.3MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.4MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.6MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)