NDA 202133

ALVOGEN

FDA Drug Application

Application #202133

Documents

• Review: 2012-04-24
• Summary Review: 2012-04-24
• Letter: 2011-10-12
• Letter: 2014-07-23
• Label: 2011-10-12
• Label: 2014-07-30
• Label: 2017-01-06
• Label: 2017-01-06
• Medication Guide: 2017-01-10
• Letter: 2017-01-10
• Letter: 2017-01-10
• Letter: 2021-09-23
• Label: 2021-09-24
• Medication Guide: 2021-09-24

Application Sponsors

NDA 202133

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 60MG BASE

1

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-10-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-07-18	901 REQUIRED
LABELING; Labeling	SUPPL	4	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-01-04	901 REQUIRED
LABELING; Labeling	SUPPL	12	AP	2021-09-20	901 REQUIRED

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	15
SUPPL	4	Null	6
SUPPL	5	Null	7
SUPPL	12	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

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(
    [0] => Array
        (
            [ApplNo] => 202133
            [companyName] => ALVOGEN
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/202133s004s005lbl.pdf#page=40"]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202133s004s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202133s004s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202133s004s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202133s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202133s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/06\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202133s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202133s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202133_fluoxetine_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202133Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202133s004s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202133Orig1s004,s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202133s004s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202133Orig1s004,s005ltr.pdf\"}]","notes":">"},{"actionDate":"07\/18\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202133s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202133Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-01-04
        )

)