ANDA 062801

ALVOGEN INC

FDA Drug Application

Application #062801

Application Sponsors

ANDA 062801

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	1987-07-24
LABELING; Labeling	SUPPL	3	AP	1991-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-10-30
LABELING; Labeling	SUPPL	7	AP	1994-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-08-03
LABELING; Labeling	SUPPL	13	AP	2000-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-04-09
LABELING; Labeling	SUPPL	17	AP	2004-04-16
LABELING; Labeling	SUPPL	19	AP	2005-08-12
LABELING; Labeling	SUPPL	23	AP	2008-10-08
LABELING; Labeling	SUPPL	27	AP	2013-01-18	STANDARD
LABELING; Labeling	SUPPL	30	AP	2015-06-13	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	27	Null	15
SUPPL	30	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ALVOGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62801
            [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
        )

)