Application Sponsors
NDA 017769 | SANOFI AVENTIS US | |
Marketing Status
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001 | INJECTABLE;INJECTION | 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CALCIMAR | CALCITONIN SALMON |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SALMON","strength":"200 IU\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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
)
)