ANDA 062943

ALVOGEN INC

FDA Drug Application

Application #062943

Application Sponsors

ANDA 062943

ALVOGEN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/ML

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

	ORIG	1	AP	1988-09-29
LABELING; Labeling	SUPPL	2	AP	1991-10-22
LABELING; Labeling	SUPPL	3	AP	1991-10-22
LABELING; Labeling	SUPPL	5	AP	1994-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-08-03
LABELING; Labeling	SUPPL	8	AP	2000-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-01-23
LABELING; Labeling	SUPPL	13	AP	2004-04-12
LABELING; Labeling	SUPPL	15	AP	2005-08-12
LABELING; Labeling	SUPPL	20	AP	2008-10-10
LABELING; Labeling	SUPPL	24	AP	2013-01-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	24	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ALVOGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62943
            [companyName] => ALVOGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 150MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN PHOSPHATE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 150MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)