NDA 017769

SANOFI AVENTIS US

FDA Drug Application

Application #017769

Application Sponsors

NDA 017769

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

CALCIMAR

CALCITONIN SALMON

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1978-04-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	1979-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-05-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2007-12-07
LABELING; Labeling	SUPPL	10	AP	2007-12-07
LABELING; Labeling	SUPPL	12	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-08-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	1988-03-22
LABELING; Labeling	SUPPL	17	AP	1989-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1990-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-04-04	STANDARD
LABELING; Labeling	SUPPL	20	AP	1991-04-08
LABELING; Labeling	SUPPL	21	AP	1992-06-01
LABELING; Labeling	SUPPL	22	AP	1992-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-07-12	STANDARD
LABELING; Labeling	SUPPL	24	AP	1993-09-24
LABELING; Labeling	SUPPL	25	AP	1993-07-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-05-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17769
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIMAR","activeIngredients":"CALCITONIN SALMON","strength":"200 IU\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCIMAR","submission":"CALCITONIN SALMON","actionType":"200 IU\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)