ANDA 201094

SAGENT PHARMS INC

FDA Drug Application

Application #201094

Documents

• Letter: 2014-04-30

Application Sponsors

ANDA 201094

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

JELLY;TOPICAL

2%

0

GLYDO

LIDOCAINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-04-28
LABELING; Labeling	SUPPL	6	AP	2019-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AT

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201094
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYDO","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"JELLY;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201094Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-29
        )

)