ANDA 208191

DR REDDYS

FDA Drug Application

Application #208191

Documents

• Letter: 2016-08-31

Application Sponsors

ANDA 208191

DR REDDYS

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

2016-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208191
            [companyName] => DR REDDYS
            [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":"08\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208191s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-26
        )

)