ANDA 078329

STRIDES PHARMA

FDA Drug Application

Application #078329

Documents

• Other Important Information from FDA: 2009-03-03

Application Sponsors

ANDA 078329

STRIDES PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	400MG	0	IBUPROFEN	IBUPROFEN
002	TABLET;ORAL	600MG	0	IBUPROFEN	IBUPROFEN
003	TABLET;ORAL	800MG	0	IBUPROFEN	IBUPROFEN

FDA Submissions

	ORIG	1	AP	2009-02-05
LABELING; Labeling	SUPPL	3	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	11	Null	15
SUPPL	15	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78329
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)