ANDA 204316

HETERO LABS LTD V

FDA Drug Application

Application #204316

Application Sponsors

ANDA 204316

HETERO LABS LTD V

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
002	TABLET;ORAL	EQ 50MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
003	TABLET;ORAL	EQ 100MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
004	TABLET;ORAL	EQ 200MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
005	TABLET;ORAL	EQ 300MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
006	TABLET;ORAL	EQ 400MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-16

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204316
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)