APPLICATION
NDA017769
TYPE
NDA
ORIGINAL APPROVAL
1978-04-17
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CALCIMAR · ReferenceDiscontinued
CALCITONIN SALMON 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 8AP
2007-12-07Labeling · Supplement 12AP
2007-12-07Labeling · Supplement 10AP
1996-05-16Manufacturing (CMC) · Supplement 27 · standardAP
1993-09-24Labeling · Supplement 24AP
1993-07-12Manufacturing (CMC) · Supplement 23 · standardAP
1993-07-06Labeling · Supplement 25 · standardAP
1992-06-01Labeling · Supplement 21AP
1992-05-06Labeling · Supplement 22AP
1991-04-08Labeling · Supplement 20AP
1991-04-04Manufacturing (CMC) · Supplement 19 · standardAP
1990-03-21Manufacturing (CMC) · Supplement 18 · standardAP
1989-07-06Labeling · Supplement 17AP
1988-03-22Labeling · Supplement 16AP
1986-08-08Manufacturing (CMC) · Supplement 14 · standardAP
1984-05-10Manufacturing (CMC) · Supplement 13 · standardAP
1979-11-26Labeling · Supplement 2AP
1979-05-04Manufacturing (CMC) · Supplement 5 · standardAP
1979-04-06Manufacturing (CMC) · Supplement 4 · standardAP
1979-01-10Manufacturing (CMC) · Supplement 3 · standardAP
1978-08-14Manufacturing (CMC) · Supplement 1 · standardAP
1978-04-17Type 3 - New Dosage Form · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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