ANDA 075477

CSPC OUYI

FDA Drug Application

Application #075477

Application Sponsors

ANDA 075477

CSPC OUYI

Marketing Status

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

Application Products

001	CAPSULE;ORAL	100MG	0	GABAPENTIN	GABAPENTIN
002	CAPSULE;ORAL	300MG	0	GABAPENTIN	GABAPENTIN
003	CAPSULE;ORAL	400MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2005-03-23
LABELING; Labeling	SUPPL	2	AP	2006-01-31
LABELING; Labeling	SUPPL	6	AP	2015-11-04

Submissions Property Types

SUPPL

6

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CSPC OUYI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75477
            [companyName] => CSPC OUYI
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"400MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)