ANDA 078801

SYNTHON PHARMS

FDA Drug Application

Application #078801

Application Sponsors

ANDA 078801

SYNTHON PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.4MG

0

TAMSULOSIN HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-04-27
LABELING; Labeling	SUPPL	4	AP	2011-10-17

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78801
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)