ANDA 085998

ACTAVIS LLC

FDA Drug Application

Application #085998

Application Sponsors

ANDA 085998

ACTAVIS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

HYDROXOCOBALAMIN

HYDROXOCOBALAMIN

FDA Submissions

	ORIG	1	AP	1978-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	1986-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1989-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1989-05-09
LABELING; Labeling	SUPPL	71	AP	1992-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1997-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1996-12-04
LABELING; Labeling	SUPPL	74	AP	1997-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	1999-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1999-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1999-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1999-11-22
LABELING; Labeling	SUPPL	80	AP	1999-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	2000-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	2000-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	2000-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	2000-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	86	AP	2002-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	2001-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	2001-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	2002-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	2001-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	2002-07-08

Submissions Property Types

SUPPL	66	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	75	Null	0
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	79	Null	0
SUPPL	80	Null	1
SUPPL	81	Null	0
SUPPL	83	Null	0
SUPPL	84	Null	0
SUPPL	85	Null	0
SUPPL	86	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	89	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0

CDER Filings

ACTAVIS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85998
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXOCOBALAMIN","activeIngredients":"HYDROXOCOBALAMIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXOCOBALAMIN","submission":"HYDROXOCOBALAMIN","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)