ANDA 202338

MYLAN PHARMS INC

FDA Drug Application

Application #202338

Application Sponsors

ANDA 202338

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	CAPSULE;ORAL	EQ 75MG HYDROCHLORIDE	0	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE
002	CAPSULE;ORAL	EQ 100MG HYDROCHLORIDE	0	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE
003	CAPSULE;ORAL	EQ 125MG HYDROCHLORIDE	0	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE
004	CAPSULE;ORAL	EQ 150MG HYDROCHLORIDE	0	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE

FDA Submissions

	ORIG	1	AP	2013-06-28
LABELING; Labeling	SUPPL	2	AP	2020-04-27	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202338
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIPRAMINE PAMOATE","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 75MG HYDROCHLORIDE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IMIPRAMINE PAMOATE","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 100MG HYDROCHLORIDE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IMIPRAMINE PAMOATE","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 125MG HYDROCHLORIDE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IMIPRAMINE PAMOATE","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 150MG HYDROCHLORIDE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/27\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-27
        )

)