ANDA 091479

TORRENT PHARMS LTD

FDA Drug Application

Application #091479

Documents

• Letter: 2012-11-07

Application Sponsors

ANDA 091479

TORRENT PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 20MG BASE

0

SILDENAFIL CITRATE

SILDENAFIL CITRATE

FDA Submissions

	ORIG	1	AP	2012-11-06
LABELING; Labeling	SUPPL	2	AP	2014-08-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-04-03	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-12-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-04-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-04-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91479
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SILDENAFIL CITRATE","submission":"SILDENAFIL CITRATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)