ANDA 070755

WOCKHARDT BIO AG

FDA Drug Application

Application #070755

Application Sponsors

ANDA 070755

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

EQ 300MG CARBONATE/5ML

0

LITHIUM CITRATE

LITHIUM CITRATE

FDA Submissions

	ORIG	1	AP	1986-05-21
LABELING; Labeling	SUPPL	2	AP	1987-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-03-25
LABELING; Labeling	SUPPL	5	AP	1989-03-27
LABELING; Labeling	SUPPL	6	AP	1990-08-29
LABELING; Labeling	SUPPL	7	AP	1994-08-12
LABELING; Labeling	SUPPL	8	AP	1996-02-05
LABELING; Labeling	SUPPL	9	AP	1997-04-22
LABELING; Labeling	SUPPL	13	AP	2008-04-28
LABELING; Labeling	SUPPL	14	AP	2022-10-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-10-13	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	14	Null	7
SUPPL	15	Null	7

TE Codes

001

Prescription

AA

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 70755
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)